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Specialty Pharma Newsletter -May-September 2014 

Sept 11   FDA approves weight-management drug Contrave.  The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.  The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

Sept 11   Small Business Chronicles: Registration and Drug Listing    The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Who, What, When, and How of Registration and Drug Listing.  Obtain your copy at:   Registration and Drug Listing. 

Sept 12   Recalls – Class II

Paroxetine HCL Controlled-Release Tablets 10 mg, 12.5 mg, 20 mg, 25 mg, 37.5 mg, and 40 mg, 30-count bottles and Paxil Oral Suspension, Rx only.   Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328.   Reason:  Chemical Contamination: Products were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. 

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21.  Reason:  Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. 

Sept 10   FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas.  The FDA has issued a formal request to Downing Labs (dba NuVision Pharmacy in Dallas) for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. In the letter, the FDA outlined poor conditions and practices identified by FDA investigators during a July 2014 inspection of Downing Labs’ Dallas facility. In the letter, the FDA outlined the practices and facility conditions that raise concerns about the sterility assurance of purportedly sterile drug products made at the Downing Labs facility.  Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death. 

Sept 10  FDA publishes Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.  The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).  The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product).

Sept 9     CDER SBIA Webinar on “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files” – September 16, 2014.  This webinar will provide a brief demo of CDER Direct, a new software application to assist companies in submitting drug registration and listing submissions.   To register for this Event, please go the following link:    https://collaboration.fda.gov/sbia0916/event/registration.html  Registration password needs to be 8 characters and alphanumeric. 

Sept 8     Guidance Webinar Invitation: "Uncomplicated Gonorrhea: Developing Drugs for Treatment".  On Thursday, September 11, 2014, from 10:00 a.m. – 11:00 a.m. EDT, FDA will present a webinar on this draft guidance for industry.  The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea.  To access this webinar, click on the following access link:  https://collaboration.fda.gov/guidancewebinars/.   The full announcement of the Webinar is found here:   http://www.fda.gov/Training/GuidanceWebinars/ucm412324.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery    

Sept 5     Warning Letters

Issued to MicroTest, 104 Gold St, Agawam, MA 01001.  Reason: failure to pay the appropriate facility fee as required by GDUFA. Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded or processed at such a facility are misbranded. Your facility has been placed on a publicly available GDUFA facility arrears list for failure to pay required fees in 2013 and 2014.  

Sept 5     Guidance for Industry:  Electronic Submission of Lot Distribution Reports (PDF-62KB).  You can download this guidance at:   Electronic Submission of Lot Distribution Reports (PDF - 62KB)

Sept 4      Drug Information Update- FDA approves Keytruda for advanced melanoma.  The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.  Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. 

Sept 3     Recalls – Class III 

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only.  Manufactured by Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.  Reason:  Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. 

Aug 26   FDA posts Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.   This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development.  This guidance also describes FDA’s process for providing communications related to such correspondence. A pre-recorded webinar explaining this draft guidance is available at :  CDER Small Business and Industry Assistance (CDER SBIA) Webinar “Draft Guidance for Industry on Controlled Correspondence Related to Generic Drug Development” – August 26, 2014    You can download this draft guidance at:    Controlled Correspondence Related to Generic Drug Development 

Aug 26   FDA’s new Web-based Learning Course “Human Drug Establishment Registration and Drug Listing Compliance” is available at:  http://www.accessdata.fda.gov/cder/sb-drls/index.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery    

Aug 20   Recalls – Class I

Super ARTHGOLD 500mg, 120 Capsule Bottles, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5.  Reason:  Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. 

Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption.  30 pills /Bottle, Distributed by: Bacai, Inc.   Reason:  Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.

Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only.   Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer, Inc., New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23.  Reason:  Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0 

Aug 20  Drug Information Update - FDA approves new drug to treat a form of Gaucher disease.  The U.S. Food & Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.  Type 1 Gaucher disease is estimated to affect about 6,000 people in the US. 

Aug 19   FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop.    It will be held on October 21, 2014, 8:00 AM to 5:00 PM at the Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814.  There is no registration fee for the public workshop, but for planning purposes, please register at the following site:  https://www.surveymonkey.com/s/BreastWorkshop2014  

Aug 19   Revised Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products-Considerations, Content, and Format.  This draft guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. You can download at:Guidance Document 

Aug 19   FDA Announces GDUFA Public Hearing on Policy Development.  It will be held September 17, 2014 from 9:00 AM to 5:00 PM at the College Park Marriott. 3501 University Blvd., East Hyattsville, MD 20783.   Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation.  FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics.  Learn more at:  http://www.fda.gov/Drugs/NewsEvents/ucm409381.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Aug 15   Drug Information Update - Turkish Man Pleads Guilty to Importing Illegal Cancer Drugs.   Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.  Akman pleaded guilty in the U.S. District Court for the Eastern District of Missouri, in St. Louis, Missouri, where he initially shipped his illegal drugs. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States. 

Aug 15   Drug Information Update - FDA warns consumers about fraudulent Ebola treatment products.   The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.  There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. 

Aug 15   Drug Information Update - FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer.  The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.  Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.   Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

Aug 15   FDA Small Business & Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014. This event is free. It will be held on September 18-19 at the Hyatt Regency Bethesda in Bethesda, MD. The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation & Research (CDER) & Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant & helpful information on the key aspects of drug & device regulations. Our primary audience is that of small manufacturers of drug &/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices. To register go to:     https://www.signup4.net/public/ap.aspx?EID=FDAS18E&OID=130   

Aug 14   Guidance for Industry - Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products – Considerations, Content, and Format.    You can download this guidance at: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Considerations, Content, and Format (PDF - 117KB)

Aug 14   Drug Information Update - FDA approves Belsomra (suvorexant) to treat insomnia.  The U.S. Food and Drug Administration on August 13, 2014 approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.  Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily.  The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness. 

Aug 13   Recalls – Class III

Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only.  Manufactured by: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10.   Reason: Presence of Foreign Substance; tablets may contain stainless steel metal particulates. 

Aug 13   Recalls – Class II

All injectables sold by Medical Supply Liquidators, LLC., Clive, Iowa. Reason: Marketed without an Approved NDA/ANDA; IM & SQ injectable products are being recalled because the mnfg firm is not registered with the FDA as a drug manufacturer.

Numerous Durmamedics and Therametrics Skin Creams and Systems.   Distributed by Dermamedics, LLC. Oklahoma City, OK.   Reason:  Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Aug 7   Drug Information Update - FDA approves Orbactiv to treat skin infections.  The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.  Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously.

Aug 6     Guidance for Industry – Upper Facial Lines: Developing Botulinum Toxin Drug Products.   You can download this guidance at:   Upper Facial Lines: Developing Botulinum Toxin Drug Products (PDF - 240KB)  

Aug 5    Guidance for Industry – Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.  You can download this guidance at:  Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (PDF - 99KB)

Aug 1     Drug Information Update- FDA approves Jardiance to treat type 2 diabetes.    The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. 

Aug 1     FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates.   Today the U.S. Food and Drug Administration (FDA) published the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA).   For FY 2015, the generic drug fee rates are: ANDA ($58,730), PAS ($29,370), DMF ($26,720), domestic API facility ($41,926), foreign API facility ($56,926), domestic FDF facility ($247,717), and foreign FDF facility ($262,717). These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.   You can review the Federal Register Notice at:  the fiscal year 2015 generic drug user fee rates 

Jul 30 Recalls – Class I and II

Shamrock Medical Solutions Group LLC, Lewis Center, Ohio, has initiated recalls on its products due to labeling mix-ups where the product labeling is not correct for the product in the package.  Product labeling included in these recalls are:  Diltiazem HCl Capsules, Oxycodone HCL Oral Concentrate, Metformin ER Tablets, Pramipexole Dihydrochloride Tablets, Sulfamethoxazole and Trimethoprim Tablets, and Docusate Calcium Softgel Capsules.         

Franck’s Lab,Inc, dba Trinity Care Solutions, Ocala, FL has initiated a recall of 30 of its products because there is a lack of assurance of sterility. All lots of sterile products compounded by the pharmacy within exp are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Jul 30     Recalls – Class III  

Orphenadrine Citrate Extended Release Tablets, 100 mg a) 100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only.   Manufactured by Sandoz Inc., Princeton, NJ 08540.    Reason:  Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. 

Jul 29    FDA Listing of Authorized Generics as of Jul 29, 2014. Download list at: FDA Listing of Authorized Generic Drugs 

Jul 29    The Sixth Annual Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration’s Office of Medical Policy and the Duke University School of Medicine, is now open for registration.  This extensive 3-day course starting November 4, focuses on nonclinical, early clinical, and phase 3 studies; issues in the design and analysis of trials; safety and ethical considerations; and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Attendees will have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research. The course is designed for physicians, nurses, pharmacists, and other health care professionals involved in clinical trials- cost $150.   For information and how to register:  http://continuingeducation.dcri.duke.edu/CITC?source=govdelivery&utm_medium=email&utm_source=govdelivery   

Jul 28     Guidance for Industry – (Draft) Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.  Download at:   Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 105KB) 

Jul 25     FDA has published notices in the Federal Register announcing the availability of two draft guidance for industry:

1)    Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under   GDUFA

2)     Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA

Control/Click to follow the above links. 

Jul 25     Recalls – Class III

Teva Pharmaceuticals USA is recalling the following products due to failed impurities/degradation specifications:                Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only,                Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, sold by Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 

Jul 24     FDA approves new extended-release oxycodone with abuse-deterrent properties. The U.S. Food & Drug Administration approved Targiniq ER (oxycodone hydrochloride & naloxone hydrochloride extended-release tablets) an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment & for which alternative treatment options are inadequate. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death. 

Jul 23    FDA approved Zydelig (idelalisib) for three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned or relapsed. Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL. 

Jul 21     Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging.  American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016.

Jul 18     Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs  The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act.     According to the indictment, as of July 2004, FedEx employees had identified over 200 accounts that were associated with online pharmacies. By September of 2010, the list had increased to over 600 online pharmacy accounts.

Jul 16    Voluntary Nationwide Recall of Tattoo Ink, Tattoo Needles, Tattoo kits due to Microbial contamination.  White & Blue Lion, Inc. in the City of Industry, CA is recalling all lots of tattoo Inks and tattoo needles due to pathogenic bacterial contamination. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. As of an extra precaution, we are also recalling all tubes and ink cups as well. The recall includes all tattoo ink, tattoo needles, tubes, ink cups distributed by White & Blue Lion.

July 11    Guidance for Industry – Draft - Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act    You can download a copy at:  Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act (PDF - 114KB)

Jul 11    Dumb and Dumber - Charles Products Recalls Decorative Pint And Shot Glasses Due To Possible Health Risk.  Charles Products, Inc. (CPI) announced today that it is voluntarily recalling shot and pint glasses identified below sold exclusively through M&M’S World retail stores in New York, Las Vegas, Orlando and London.  The company became aware that the glassware may exceed the Food and Drug Administration’s (“FDA”) guidance levels for leachable lead and cadmium. Both lead and cadmium are heavy metals found in the environment that accumulate in human bodies. Both can cause serious health complications at high levels. These glasses should therefore be returned and should not be used for the consumption of beverages, alcoholic or otherwise. 

Jul 8      The Following Products have been cited by the FDA because they contain a Hidden Drug Ingredient (sibutramine or sildenafil):

1)      Trim Fast Slimming Softgel

2)      Sliming (sic) Diet by Pretty White

3)      Lipo 8 Burin Slim Capsules

4)      24 Ince

5)      Lingzhi Cleansed Slim Tea

6)      Mix Fruit Slimming

7)      Gold Viagra

8)      Miraculous Evil Root

9)      Sport Burner

10)    Toxin Discharged Tea

11)    Burn 7 Capsules (also contain phenolphthalein)

12)    Gold Reallas (contains Thiosildenafil)

13)    Full Throttle On Demand (contains propoxyphenyl sildenafil)

These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 

Jul 8       Draft Guidance for Industry – Best Practices in Developing Proprietary Names for Drugs   You can download this guidance at:  Draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs

Jul 8       Over-the-Counter Drug Monograph System-Past, Present, and Future; Public Hearing; Reopening of the Comment Period   FDA is reopening the comment period for the notice of public hearing, published in the Federal Register of February 24, 2014 (79 FR 10168), requesting comment on how to improve or alter the current Over-the-Counter (OTC) Monograph Process for reviewing nonprescription drugs marketed under the OTC Drug Review. FDA is reopening the comment period to update comments and to receive any new information.

Jul 3       FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma   The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program.  PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous.

Jun 27   FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots   On June 19, 2014, FDA announced it is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins, also known as venous thromboembolism, including deep vein thrombosis and pulmonary embolism. The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to the labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure that this risk is described consistently in the labeling of all approved testosterone products.  Go to this website to listen:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm402860.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery    

Jun 27    FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning    Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.  In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.  Recommended alternatives: Use a teething ring chilled in the refrigerator (not frozen), or gently rub or massage the child’s gums with your finger to relieve the symptoms. 

Jun 26       FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products   The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.  They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

Based on the information reported to FDA, we cannot determine if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both.  The hypersensitivity reactions may occur within minutes to a day or longer after product use.   Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue; hives or itching. 

Jun 25    FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment  with intravenous chemotherapy drug, docetaxel, contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. 

Several forms of docetaxel are currently marketed including generics and the brand-name products Taxotere, Docefrez, and Docetaxel Injection. The various products contain different amounts of alcohol, which health care professionals should be aware of in order to monitor and counsel patients appropriately. 

Jun 24    Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product & Notification.  The Drug Supply Chain Security Act of 2013 requires FDA to issue draft guidance to help certain trading partners (manufacturers, repackagers, wholesale distributors & dispensers) identify suspect products & must begin notifying FDA if it suspects it has illegitimate product in its possession on Jan 15, 2015. This guidance also provides information for supply chain stakeholders about how to notify FDA when they determine that they have an illegitimate product, and how to terminate that notification, consulting with FDA, should it no longer be necessary.  You can download this guidance at:     Guidance for Industry - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification 

Jun 13    Guidance for Industry: Q4B Annex 6: Uniformity of Dosage Units General Chapter   You can get your copy at:   Q4B Annex 6: Uniformity of Dosage Units General Chapter (PDF - 53KB) 

Jun 12    Guidance for Industry: ANDA Submissions--Content and Format of Abbreviated New Drug Applications   Download at:    ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 215KB) 

Jun 9      Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices    You can receive a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400104.pdf 

Jun 4      Recalls – Class II

Cefpodoxime  Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Mnfd in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20. Reason:Presence of Particulate Matter: Presence of stainless steel particles.

May 30  The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.  Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

May 29  Blog: FDA’s Final Guidance on Expedited Drug Approvals.  Read at:  http://blogs.fda.gov/fdavoice/index.php/2014/05/fdas-final-guidance-on-expedited-drug-approvals-fueling-innovation-and-helping-patients/?source=govdelivery&utm_medium=email&utm_source=govdelivery   

May 29  Guidance for Industry – Expedited Programs for Serious Conditions-Drugs & Biologics   Download at:  Expedited Programs for Serious Conditions – Drugs and Biologics (PDF - 276KB) 

May 29 Guidance for Industry – Product Development Under the Animal Rule   Download at:  Product Development Under the Animal Rule (PDF - 2MB) 

May 29  “JumpStarting” Drug Review    The JumpStart service is modernizing the drug review process—medical reviewers are using this service to quickly and thoroughly assess data from drug clinical trials, ensuring safe and effective products are approved for public use.  Read at:  http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm397921.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery  

May 23  The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.  Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is administered intravenously.

May 19  NIH:  Longevity Gene Linked to Better Brain Skills.  Read more at:  http://www.nih.gov/researchmatters/may2014/05192014brain.htm 

May 19  2014 GDUFA and You Conference Slides Now Posted   The slides for the “GDUFA and You 2014 Conference” are now posted on our website at:  2014 GDUFA and You Conference Presentation Slides1

May 15  FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose   The U.S. Food and Drug Administration (FDA) is warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness.  As a result, we have decreased the recommended starting dose of Lunesta to 1 mg at bedtime. 

May 15  FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin   FDA announced that in its ongoing review of the blood thinner Pradaxa (generic name dabigatran), FDA recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin (Coumadin, Jantoven and generics), for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal bleeding, myocardial infarction, and death. Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation.    Patients should not stop taking Pradaxa (or warfarin) without first talking to their health care professional. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death.  

May 15  Small Business Chronicles: Drug Shortages – Make an Impact    The topic of this month’s issue of the FDA/CDER Small Business Chronicles is Drug Shortages – Make an Impact  Obtain your copy at:     Drug Shortages 

May 14  Guidance for Industry:  ANDAs – Stability Testing of Drug Substances and Products Q&A  Download your copy at:   guidance document  

May 14   Guidance for Industry:  Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product   Download your copy at:   Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (PDF - 142KB) 

May 5    Guidance for Industry: CMC Post-Approval Manufacturing Changes To Be Documented in Annual Reports  Download at:  Guidance Document

Apr 30    FDA approves Zykadia for late-stage lung cancer  The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).  Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizo, tinib, the only other approved ALK tyrosine kinase inhibitor.

Apr 24   FDA approves Sylvant for rare Castleman’s disease  The U.S. Food & Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).  MCD causes an abnormal overgrowth of immune cells in lymph nodes & related tissues in the body. The disease usually affects adults who often suffer from fever, night sweats, weight loss & weakness or fatigue because their body’s immune system is weakened & cannot fight infections.  Sylvant is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8).

Apr 17 &nbs, p; FDA approves Ragwitek for short ragweed pollen  The U.S. Food & Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.  Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ra, ,, g, , , weed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home. 

Apr 17  Guidance for Industry – Comprehensive List of Guidance Documents   Download at:  Comprehensive List of Guidance Documents (PDF - 846KB)

Apr 17   Guidance for Industry – Center for Drug Evaluation and Research List of Guidance Documents New/Revised/Withdrawn Jan 1 – June 30, 2014   Download at:  New/Revised Withdrawn List for 2014 (PDF - 66KB)

 

Specialty Pharma Newsletter - January-April 2014 

Apr 16   FDA Webinar:  Draft Guidance for Industry - Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.   On Wednesday, AOn Wednesday, April 23, 2014, from 1:00 p.m. – 2:00 p.m. EDT, FDA will present a webinar on the draft guidance for industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.

Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers. Webinar access linkhttps://collaboration.fda.gov/gfiwebinar 

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties emailJeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.

To download the guidance, go to:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM388568.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Apr 16   Warning Letters

Issued to Driven Sports, Inc., 672 Dogwood Avenue, Suite 329, Franklin Square, NY 11010.  Reason:  Their product CRAZE which is labeled as a dietary supplement, contains a new dietary ingredient which makes it adulterated under section 402(f) of the Act [21 U.S.C. 342b (a) (2) and 21CFR 190.6.

 Issued to Aloe Man International Corp., 18800 NW 2nd Avenue, Suite 102, Miami, FL.  Reason: Their products Gap Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator are products promoted for conditions that cause them to be drugs within the meaning of  section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].  The therapeutic claims on your labeling establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 

Issued to Deseo Rebajar Inc., P.O. Box 7218, Humacao, PR 00792.  Reason:  Your products, "Adipotrim XT," "Burn 7," "Reductrol Fat Burner Formula," ''Adipocleanse," "Adipocleanse XT," "Lipozene," and "Slim Patch" are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FDCA [21 U.S.C. §§ 352 and 331(a)] 

Apr 15   Drug Information Update – FDA Approves Tanzeum to Treat Type 2 Diabetes  The U.S. Food & Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control along with diet & exercise, in adults with type 2 diabetes. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety & effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Apr 11   FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension.  In Aug 2012 FDA added the warning “use of Revatio, particularly chronic use, is not recommended in children” to Revatio’s drug label. A FDA Drug Safety Communication was also issued.  This recommendation was based on clinical trial results showing a higher mortality risk in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose.

Apr 11   The products “Infinity” and “Lite Fit USA” Contain a Hidden Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use Infinity or Lite Fit USA, products promoted and sold for weight loss on various websites, and in some retail stores.  FDA laboratory analysis confirmed that Infinity contains sibutramineSibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. 

Apr 10   Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act.  This guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities (outsourcing facility) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm391102.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 9     Guidance for Industry:  Immunogenicity-Related Considerations for Approval of Low Molecular Weight Heparin for NDAs and ANDAs.   You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM392194.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 9     Recalls – Drugs Class III

Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only.   Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13.  Reason:  Cross Contamination with Other Products: Product contains Promecta (eltrombopag).

Recalls – Drugs Class II

Duloxetine Delayed-Release Capsules, USP, 20 mg, 30 mg, and 60 mg, Rx Only, 60 capsules per Bottle.   Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06.  Reason:   Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

HydrOXYzine HCl Tablets, USP 25 mg and 50 mg, 100 Tablet Blister, Rx only.   Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01.  Reason:  Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Apr 7     The U.S. Food & Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss & body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label. The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the USt. All products that have been tested, including those that claim to be “genuine” and “anti-counterfeit,” have been found to contain one or both of the following undeclared drug ingredients:  Sibutramine – a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.   Phenolphthalein – a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.  The FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Reports have included heart palpitations, tachycardia (increased heart rate), suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have experienced any negative side effects while taking this product should consult a health care professional.

Apr 3     Public Workshop:  Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.  FDA will hold the public workshop May 8-9, 2014, at FDA’s White Oak campus in Silver Spring, MD.  You must register by April 24, 2014.  Registration is free. Seats are limited. For more information and registration instructions, please visit:  http://www.fda.gov/Drugs/NewsEvents/ucm388993.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery                                              

Send questions to: DrugTrackandTrace@fda.hhs.gov        

Apr 2    Public Notification: New You Contains Hidden Drug Ingredients: Sibutramine and Phenolphthalein.  Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.”   

Mar 31   Drug Information Update - FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension.  FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with pulmonary arterial hypertension. 

Mar 31   FDA warns consumers not to purchase or use weight loss product Alli.  The U.S. Food and Drug Administration is alerting consumers that GlaxoSmithKline (GSK) is withdrawing all lots of its weight loss product Alli from the U.S. market because some packages were tampered with and may contain other kinds of pills. 

Mar 31 Five New Guidance Documents

1. Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices.  FDA’s recommended practice when discussing unapproved new uses for approved drugs marketed in the US.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

2. Drug Development to Treat the Symptoms of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.

This guidance will assist sponsors in development of drugs for treatment of VFS/ME.  Download at:  http://www.fda.gov/drugs/newsevents/ucm319188.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery   

3. Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.  This guidance gives the FDA’s requirements pertaining to allowable excess volume in injectable vials.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm389069.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

4. Draft Guidance for Industry on Bioavailability and Bioequivalence Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations.  This draft guidance revises those parts of the March 2003 guidance entitled “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations”.   Download Federal Register Notice at:   https://www.federalregister.gov/articles/2014/03/18/2014-05849/draft-guidance-for-industry-on-bioavailability-and-bioequivalence-studies-submitted-in-new-drug?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov  

5. Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.   The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm390058.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 31  Nova Products, Inc. Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical IngredientsNova Products, Inc. of Aston, Pennsylvania is voluntarily recalling the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012) at the retail level due to undeclared sildenafil and tadaiafil.

Mar 27  All manufacturers of prescription combination drug products with more than 325 mg of acetaminophen have discontinued marketing.   FDA and industry have taken action to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen. 

Mar 26   Pure Edge Nutrition, LLC Issues Voluntary Nationwide Recall of Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein.  The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.

Mar 26   New Life Nutritional Center Issues Voluntary Nationwide Recall of Super Fat Burner, Maxi Gold and Esmeralda Dietary Supplements Due to the Presence of Undeclared Sibutramine and Phenolphthalein.  The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. 

Mar 26  Warning Letters – Issued to Mr. Eaga Purushotham, Smruthi Organics Ltd., Solapur, 413 001 India citing the following:

1. Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of your APIs to established specifications and standards.

2. Failure to maintain and make available for inspectional review production and control records for currently marketed APIs.                                                                                                                                 

3. Inadequate investigations of critical deviations or a failure of a batch to meet its specifications or quality standards.

Mar 25   FDA approves Otezla to treat psoriatic arthritis.  The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).  PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

Mar 24   Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.  You can view the slides from this presentation at:  http://www.fda.gov/downloads/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/UCM389827.pdf

Mar 21   CDER SBIA Chronicles: GDUFA – Where Are We Now?  The topic of this month’s issue of the FDA/ CDER Small Business Chronicles: GDUFA – Where Are We Now?  You can download your copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM390003.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 19   Public Notification: Vitaccino Coffee Contains Hidden Drug Ingredient.  This product was promoted and sold for weight loss and sold on various websites and in some retail stores.  FDA laboratory analysis confirmed that Vitaccino Coffee contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons.

Mar 17   Recalls – Class III 

Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only. Manufactured for: Qualitest Pharmaceuticals, Huntsville,  AL NDC 51079-819-20.  Manufactured by: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Rockford, IL.   Reason:  Failed Impurity/degradation Specification.

Mar 17   Recalls – Class II 

Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only, C IV. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50.  Reason: Failed Tablet/Capsule Specifications:   Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Mar 17   SNI National is Voluntarily recalling Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 pack Due to Undeclared Drug Ingredients.  These products contain Kratom (Mitragyna Speciosa).  Kratom is a botanical that qualifies as a dietary ingredient under section 201(f) (1) of the Federal Food, Drug, and Cosmetic Act. When marketed as a dietary ingredient, FDA considers kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.

Mar 13   CDER Export Certificate Program Frequently Asked Questions.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCompliance/UCM388842.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 13   Pain Free by Nature is Voluntarily Recalling Reumofan Plus Tablets Due to Undeclared Drug Ingredients.  Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased because they contain undeclared active pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries (specific injuries were not detailed in the article).

Mar 12   Recalls – Class II

Cyano B-12 (Cmpd) 1000mcg/ml, Dexamethasone (pf) 0.05 % opth., Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic, Dexamethasone phosphate 24mg/ml inj., Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg, Testosterone Cypionate 200mg/ml, Triamcinolone Acetonide 3mg/ml, Vancomycin (fortified) 25mg/ml opth, Vit A (olive oil) 0.1% opth., Vitamin D (Ergocalciferol) 800 u/ml, and Voriconazole 1% opthal.  Manufactured by Natures Pharmacy & Compounding Center, Ashville, NC.  Reason:  Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Mar 12   The FDA Website “Abbreviated New Drug Application (ANDA) Forms and Submission Requirements” has been updated.  View at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm120955.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 12   The FDA Website, “Generic Drugs: Information for Industry” has been updated.  View at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery   

Mar 7    The FDA Website, “Opioid Patient-Prescriber Agreement” has been updated.  View at: http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm377231.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 7     Pfizer Initiates Nationwide Voluntary Recall of Two Lots of Pfizer’s Effexor XR® 150 Mg Extended-Release Capsules and One Lot of Greenstone’s Venlafaxine HCl 150 Mg Extended-Release Capsules Due to the Possible Presence of Tikosyn® Capsules.  Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.  This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) 0.25mg in addition to the Effexor XR capsules

Mar 5     Guidance for Industry:  CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.    You can download a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 28    Guidance for Industry – Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387446.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 26   Drug Information Update – FDA approves Myalept to treat rare metabolic disease.  On Feb. 24, 2014, the U.S. Food and Drug Administration approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.  Generalized lipodystrophy is a condition associated with a lack of fat tissue. Patients with congenital generalized lipodystrophy are born with little or no fat tissue. Patients with acquired generalized lipodystrophy generally lose fat tissue over time. Because the hormone leptin is made by fat tissue, patients with generalized lipodystrophy have very low leptin levels. Leptin regulates food intake and other hormones, such as insulin. 

Feb 26    FDA’s GDUFA Regulatory Science Initiatives Public Meeting.    FDA is hosting “The Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15” Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2015 research priorities.  FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2015 Regulatory Science Plan.   The meeting will be held at FDA’s main campus in Silver Spring, MD, on May 16, 2014, from 9:00am-5:00pm and will be webcast for those who cannot attend in person.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.  If you wish to attend, either in person or via webcast, or present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov by April 25, 2014. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number). Those without email ? access can register by contacting Thushi Amini (Thushi.Amini@fda.hhs.gov) by April 25, 2014. If you need special accommodations because of a disability, please contact Thushi Amini at least seven days before the hearing.

Feb 24    Guidance for Industry – New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.   Download this draft guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386685.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 24    Guidance for Industry – Analytical Procedures and Methods Validation for Drugs and Biologics.  Download this draft guidance at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386366.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 18   CDERWorld is a series of educational modules based on The CDER Forum for International Regulatory Authorities Lectures.  The modules present an overview of the work of the Center for Drug Evaluation and Research. After a hiatus, CDERWorld is alive again on our website.  CDER World is an ever-growing compendium of information about how CDER carries out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science to improve the public health. Please take some time to check out this excellent resource!  View at:  http://www.accessdata.fda.gov/scripts/cderworld/?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 19    The slides from the meeting presentation, “FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014” are available at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM388753.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 18    Drug Information Update-FDA lab testing finds N-acetyl-leucine in samples of recalled Medisca product labeled as L-citrulline.  FDA has tested samples from recalled lots of Medisca’s L-citrulline product, and has found that the samples contain N-acetyl-leucine, which is used to treat a certain type of dizziness (acute vestibular vertigo). No L-citrulline was found in the samples FDA tested.  These results reinforce the FDA’s concern about Medisca’s product labeled as L-citrulline and serve to remind patients and clinics not to use any recalled Medisca L-citrulline product with lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D.

Feb 17    MyNicKnaxs, LLC, located in Florida is announcing a recall of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction.  These products contain undeclared active pharmaceutical ingredients: Phenolphthalein, sibutramine or a combination of both. At this time no illnesses or injuries have been reported to MyKnicKnaxs, LLC, in connection with these products.

Feb 17    Ben Venue Laboratories, Inc. Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution 10%, USP,  Lot 2005479.   This voluntary recall was initiated after the discovery of a single visible glass particle in a vial within the lot listed above. There have been no complaints or adverse events related to a piece of glass in vials of this lot.

Feb 14    Public Notification - Arth-Q Contains Hidden Drug Ingredient.  The Food & Drug Administration (FDA) is advising consumers not to purchase or use Arth-Q, a product promoted & sold as a dietary supplement for joint, muscle & arthritic pain.  FDA laboratory analysis confirmed that Arth-Q contains the active ingredient, ibuprofen.

Feb 13    Introducing CDER SBIA.   Formerly known as the CDER Small Business Program, we will now be known as CDER Small Business and Industry Assistance (CDER SBIA).  CDER SBIA’s mission is to promote productive interaction with regulated domestic and international small pharmaceutical business and industry by providing timely and accurate information relating to the development and regulation of human drug products. 

Feb  11   Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Receipt Date.                Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072385.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 11    Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A (a) of the Federal Food, Drug, and Cosmetic Act.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384686.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 11    Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Standardized Study Data.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 11    Draft Guidance for Industry on Analgesic Indications:  Developing Drug and Biological Products.                This guidance provides recommendations to sponsors on the development of prescription drugs for the management of acute and chronic pain, as well as the management of breakthrough pain. Specifically, this guidance focuses on drug development and trial design issues and chemistry, manufacturing, and controls concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm384691.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 11    Guidance for Industry and FDA Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information.  You can download at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm233769.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 11    GDUFA Regulatory Science Initiatives Public Meeting and Webcast on May 16, 2014, in Silver Spring, MD.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.  If you wish to attend, either in person or via webcast, or present at the hearing, please emailGDUFARegulatoryScience@fda.hhs.gov by April 25, 2014. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number). 

Feb 7      Guidance for Industry and Food and Drug Administration Staff - Annual Reports for Approved Premarket Approval Applications (PMA).  You can download a pdf version at:  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089398.pdf  

Feb 6      FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products.  At this time, FDA has not concluded that FDA approved testosterone treatment increases the risk of stroke, heart attack, or death.  Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.  Example conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.  Other examples include problems with the hypothalamus and pituitary that control the testicles’ production of testosterone.  None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.

 Feb 5      FDA has presented the fiscal year (FY) 2013 Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report to the President and Congress. This performance report covers the period of October 1, 2012, through September 30, 2013, and presents FDA’s accomplishments for the first year of GDUFA and expectations for the future.  You can read it at:  http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM384177.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 4      The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.  Non-24 occurs in persons who are completely blind. Light does not enter their eyes and they cannot synchronize their body clock to the 24-hour light-dark cycle.  Those with the disorder may have difficulty falling asleep or staying asleep, and may wake up groggy or feeling as if they need more rest. People with non-24 may find their sleep patterns reversed -- needing to sleep during the day and to be awake at night.

Feb 3      FDA is evaluating risk of stroke, heart attack and death with FDA-approved testosterone products.  Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.  Read more at:  http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jan 31    Guidance for Industry - Guidance Agenda: New & Revised Draft Guidance CDER is Planning to Publish During Calendar Year 2014.  Download your copy at: 

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/webcontent/ucm314767.pdf

Jan 29    Recalls – Drugs Class II

Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.   Reason:   Presence of Foreign Substance: The products are being recalled because they may contain foreign substances

Jan 24    Improving the Quality of ANDA Submissions.  FDA is establishing a public docket to receive  input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements. Specifically, FDA is interested in hearing about difficulties sponsors are having developing and preparing their ANDA submissions.  FDA is also seeking input on how to best share suggestions for improving the quality of ANDAs with the generic drug industry.  Improving the quality of ANDA submissions will result in more submissions accepted for filing, fewer amendments and easily correctable deficiencies (ECDs), and ultimately, more generic drug approvals.  FDA welcomes comments at any time, but we encourage submission of electronic or written comments to http://www.regulations.gov or Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 by March 24, 2014.

Jan 22    FDA/CDER Small Business Chronicles – Improving Drug Supply Chain Integrity.   The purpose of the newsletter, the FDA/CDER Small Business Chronicles, is to provide industry with useful information to assist in all aspects of drug marketing and regulation. This newsletter is issued every other month.  Download and print your copy today:   http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM382403.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jan 22    Recalls – Drugs Class II

Numerous incidents of gross drug product mislabeling by AidaPak Service – one example:  PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304  Reason:  Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.

Jan 17    FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers.   There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

Jan 15    FDA is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce.  Read more in the Federal Register Notice at:  https://www.federalregister.gov/articles/2014/01/10/2014-00257/unapproved-and-misbranded-oral-and-injectable-drugs-labeled-for-prescription-use-containing-codeine?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Jan 14    FDA announces the Availability of a draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”.  This guidance is posted at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Specialty Pharma Newsletter - November-December 2013 

Jan 8      Recalls Class III

Cetirizine Hydrochloride Syrup, 1 mg/mL, Rx Only NDC 0603-9063-54 (120 mL bottle) and NDC 0603-9063-58 (480 mL bottle).  Distributed by Qualitest Pharmaceuticals, Huntsville, AL 35811.  Reason: Failed impurities/degradation specification – out of specification for known impurity 4-chlorobenzophenone.

G&W Fluocinolone Acetonide Cream USP 0.025% a) 15 gram (NDC 0713-0222-15) and b) 60 gram (NDC 0713-0222-60), Rx Only.  Manufactured by G&W Laboratories, Inc. South Plainfield, NJ 07080.  Reason: Failed Content Uniformity Specification at the 18 month time point.            

Jan 8      FDA approves Farxiga to treat type 2 diabetes.  The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.  Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).   An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function.

Jan 8      Guidance for Industry

Draft Guidance on Naming of Drug Products Containing Salt Drug Substances.   Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling.  You can download the draft guidance at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm379753.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Guidance on Qualification Process for Drug Development Tools.  This guidance describes the qualification process for drug development tools intended for potential use, over time, in multiple drug development programs. The guidance provides a framework for interactions between FDA and sponsors to support work towards qualification of an identified drug development tool and creates a mechanism for formal review of data to qualify the tool and ensure that the evaluation is comprehensive and reliable.  A copy can be downloaded at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm230597.pdf

Draft Prescription Drug User Fee Act V Information Technology Plan.  This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.  Download a copy at:  http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM379847.pdf   

Draft Generic Drug User Fee Act Information Technology Plan.  This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.  Get your copy at:  http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM379851.pdf

Jan 1      Recalls – Class II

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, NDC 0781-2102-01, Rx Only.  Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, N.J.  Reason:  Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin.

Carisoprodol IV (Carisoprodol Tablets USP) 350mg, RX only. Manufactured by Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked & Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 ct bottle: NDC: 54868-0816-8, 60 ct bottle: NDC: 54868-0816-4, 30 ct bottle: NDC: 54686-0816-3.  Reason:  Presence of Foreign Substance; heavy metals (chromium, titanium, etc.) and inactive components of the product were visually observed during routine stability testing.

Dec 26    Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan.  On December 26, FDA published a notice in the Federal Register announcing the availability of the Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan.  The plan explains FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the GDUFA Performance Goals and Procedures for Fiscal Years 2013 through 2017.  FDA is requesting comments from industry and other interested stakeholders as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals. You can review the 5 year plan at:  http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM379851.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 23   Deseo Rebajar, Inc., Issues Voluntary recall of Burn 7 Capsules Due to Undeclared Active Ingredient.  The FDA laboratory analysis of this dietary supplement found the Burn 7 Capsules product to contain undeclared Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, ,, , or stroke.     

Dec 23    The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.  The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of Mass Destruction. The report described a previously healthy 28-year-old male with liver failure requiring transplant after several weeks of product use. Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances.   Mass Destruction is manufactured for Blunt Force Nutrition in Sims, NC and sold in retail stores, fitness gyms, and on the Internet.

Dec 21    FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy.  The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.  Contaminated sterile drugs put patients at risk of serious infection. Health care professionals who have received the affected products should stop using them.  The FDA is aware of one adverse event associated with mineral IV injection produced by Abrams’ lot number 11142013@74. A patient who received this product was admitted to a hospital in California and had blood cultures that tested positive for Stenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infections. These include respiratory infections such as pneumonia, bloodstream infections and meningitis. In addition, Abrams identified a similar gram-negative bacterium in the same lot of mineral IV injection. 

Dec 20    Warning Letters

Issued to Jonnie R. Williams, CEO, Star Scientific, Inc., 4470 Cox Road, Suite 110, Glen Allen, VA 23060.   Reason:  Your website promotes Anatabloc for conditions that cause the product to be a drug.  In addition your Anatabloc and CigRx products contain anatabine as a dietary ingredient.  While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket approval.  To date, a premarket notification has not been submitted to the FDA, for your products containing anatabine; therefore, your products are deemed to be adultrated.        

Dec 19    Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph.  FDA issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.   This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.  You can read more at:  http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm378122.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Dec 18    Recalls – Class III

Oxcarbazepine Tablets, 150 mg, packaged in  a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100 count bottle (NDC 0054-0097-25), Rx Only.  Manufactured by Roxane Laboratories, Inc., Columbus, Ohio 43216.  Reason: Sub-Potent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

Bumetanide Tablets USP 0.5 mg  a) 100-ct Bottle, NDC 0185-0128-01 b) 500-ct Bottle, NDC 0185-0128-05, Rx Only.  Manufactured by Sandoz Inc., Princeton, NJ 08540.  Reason:  Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

Dec 18   Recalls – Class II

Phenytoin Oral Suspension USP, NDC 66689-036-5012, 5mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only. Manufactured by: Vista Pharm, Inc., Largo, FL 33771.  Reason:  Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability time point.

Dec 18    FDA to Extend Comment Period on Proposed Rule on Safety Labeling Updates By Brand and Generic Drug Manufacturers (“Changes Being Effected” Supplements proposed rule).   FDA has decided to extend the comment period by 60 days for the proposed rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” (“Changes Being Effected” Supplements proposed rule). The comment period on the proposed rule will be extended to March 13, 2014, and the comment period on information collection issues under the Paperwork Reduction Act of 1995 will be extended to February 11, 2014. 

Dec 18    The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.  Taking part in this initiative are the EMA and the EU member states France, Germany, Italy, the Netherlands and the United Kingdom.

Dec 17    FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes.  The U.S. Food and Drug Administration (FDA) is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism.  Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs.  All male patients and their caregivers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs.

Dec 12    The U.S. Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.  Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market duloxetine in various strengths.

Dec 9      Guidance for Industry:  Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.  You can download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377938.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 4      Recalls – Class I

J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack.  Marketed by Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934.  Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.

Dec 4      Recalls – Class II

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, NDC 0228-4025-11, Rx Only.   Manufactured by Actavis Elizabeth, LLC, Elizabeth, NJ,.  Reason: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets.        

Acyclovir Tablets USP 800 mg, (NDC 60505-5307-1), Rx only.  Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, Florida 33326.  Reason:  Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.

Dec 4      Guidance for Industry – Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 2      Guidance for Industry.

Interim Product Reporting for Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.   You can download this draft Guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377050.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.   You can download this draft Guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377051.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Pharmacy Compounding of Human Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.  You can download this draft Guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (Draft)

When finalized, this draft guidance will replace the guidance of the same title issued January 25, 2012. The draft guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human drugs, including biological drug products, and prescription animal drugs and articulates the circumstances under which FDA intends to exercise enforcement discretion.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070076.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 2      Federal Register Notices

Over-the-Counter Ophthalmic Drug Products – Emergency Eyewash Products; Rescheduling of Public Hearing.  FDA is rescheduling a December 4, 2013, public hearing to obtain information on the formulation, manufacturing, and labeling of currently marketed over-the-counter (OTC) emergency use eyewash products, announced in the Federal Register of Wednesday, September 18, 2013. Based on a request received by the Agency, we are rescheduling the public hearing to March 7, 2014, and updating the related procedural dates that appeared in the September 18, 2013, notice.  Read the Federal Register Notice at:  https://www.federalregister.gov/articles/2013/11/15/2013-27359/over-the-counter-ophthalmic-drug-products-emergency-use-eyewash-products-rescheduling-of-public?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Nov 29   IQ Formulations Issues a Voluntary Recall of HYDRAVAX Dietary Supplement Due to Possible Undeclared Ingredient.  IQ Formulations, of Sunrise, Florida is initiating a precautionary & proactive recall of all lots of its 45-capsule bottles of HYDRAVAX due to potential inclusion of an unlisted ingredient. The FDA has advised IQ Formulations that an analysis of a sample from one lot of HYDRAVAX (Lot # 2458, Exp # 07/16) revealed the presence of an undeclared ingredient a diuretic.

Nov 27               Recalls – Class II                                                                              

Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, NDC 0025-1031-31, Rx only.  Manufactured by G.D. Searle, Division of Pfizer, Inc., NY, NY 10017.   Reason:  Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 Capsules per bottle, NDC: 62175-118-43, Rx Only.  Manufacturer: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA.  Reason:  Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, NDC 0054-0199-59, Rx only. Manufacturer: Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216.   Reason: Re-suspension Problems: Recalled lot did not meet resuspendability requirements.

Nov 22   FDA expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.  Thyroid cancer is a cancerous growth of the thyroid gland, which is located in the neck. Differentiated thyroid cancer is the most common type of thyroid cancer. The National Cancer Institute estimates that 60,220 Americans will be diagnosed with thyroid cancer and 1,850 will die from the disease in 2013.  Nexavar works by inhibiting multiple proteins in cancer cells, limiting cancer cell growth and division. The drug’s new use is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment.  Thyroid stimulating hormone, a potential promoter of thyroid cancer, is more likely to become elevated while on treatment with Nexavar, requiring adjustment of thyroid hormone replacement therapy.

Nov 14   FDA/CDER Small Business Chronicles – Communicating with CDER.   The topic of this month’s issue of the FDA/CDER Small Business Chronicles is Communicating with CDER.   To facilitate the conduct of efficient and effective drug development programs, it is very important for potential drug sponsors to engage with CDER early in the drug development process. This newsletter discusses different avenues of communication that are available for small business to communicate with CDER.    Download your copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM374882.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Nov 13   Recalls – Class II

Ciprofloxacin Tablets, USP, 500 mg, 250 mg,  100-count bottles, NDC 0378-7098-01 and NDC 0378-7097-01,  Rx only.  Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.   Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Amlodipine Besylate & Benazepril HCl Capsules, All Strengths, 100-ct bottles, NDC 0378-6900-01 & others, Rx only.  Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.   Reason:  CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.          

Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-ct bottles (NDC 0378-4254-91) & b) 500-ct bottles (NDC 0378-4254-05), Rx only.  Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.  Reason:  CGMP Deviations: Pharmaceuticals were produced & distributed with active ingredients not manufactured according to GMP.

Nov 12   Guidance for Industry

ANDA Submissions – Refuse to Receive Standards.  Published in October 2013, you can download a copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352?source=govdelivery&utm_medium=email&utm_source=govdelivery                   

Nov 8     FDA Approves First Generic Versions of Aciphex Delayed-Release Tablets to Treat GERD.  The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).   GERD, also called acid reflux or acid regurgitation, is a common condition in which backward flow of acid from the stomach causes heartburn and possible injury to the esophagus (the tube that connects the throat and stomach).   Dr. Reddy’s Laboratories Ltd., Kremers Urban Pharmaceuticals Inc., Lupin Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic rabeprazole.

Nov 6     FDA takes two important actions on drug shortages.  FDA is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients.   First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.  Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements included in FDASIA.  To read the proposed rule, go to:  https://www.federalregister.gov/articles/2013/11/04/2013-25956/permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Nov 6    Guidance for Industry

Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.   Download a copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071185.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Nov 4     Perrigo Initiates Nationwide Voluntary Product Recall of 18 Batches of Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, Due to a Potential Defect with the Co-packaged Oral Syringe.  The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings.

Nov 4     Guidance for Industry

ANDAs: Stability Testing of Drug Substances and Products.  Download a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072873.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                              A companion guidance is also available: Questions and Answers.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Nov 4     Drug Information Update - Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal.  The U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals $1,673,024 billion.

Nov 1     Drug Information Update - Proposed Hydrocodone Reclassification.  In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which would increase the controls on these products.  Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency’s intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule.  By early December, FDA plans to submit this formal recommendation package to HHS.

Specialty Pharma Newsletter - Sept-Oct 2013 

Oct 18    OPDP Enforcement Actions Webinar –  January 30, 2014 at 11:00 AM.   The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) invites you to participate in the next Enforcement Webinar on January 30, 2014, from 11:00 AM to 12:00 PM (ET). Viewers can begin submitting questions 30 minutes prior to the webinar start time. During the webinar, OPDP will give stakeholders a chance to directly communicate with the Agency about clarifications or questions concerning recent Warning Letters and Untitled Letters issued by OPDP. This particular webinar will cover Warning Letters and Untitled Letters issued from July 2013 through September 2013. To join the meeting: https://collaboration.fda.gov/opdp1028

Oct 18    Warning Letters

Issued to Nephron Pharmaceuticals Corporation, 4121 SW 34th Street, Orlando, FL 32811.  Reason:

The over-the-counter (OTC) drug product Asthmanefrin (NDC 0487-2784), a bronchodilator contains the active ingredient racepinephrine hydrochloride.  Based on the active ingredient and the claims made for this product, Asthmanefrin is a "new drug" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled uses. 

Issued to Dolgencorp, Inc., 100 Mission Ridge, Goodiettsville, Tennessee 37072, 

Homeolab USA 3025 boul de l’Assomption Blvd., Montreal, QC H1N 2H2 Canada,

Insight Pharmaceuticals, LLC, 900 Northbrook Drive, Suite 200, Trevose, PA 19053,

Medtech Products, Inc., 90 N. Broadway, Irvington, NY 10533, and

Topco Associates, LLC, 7711 Gross Point Road, Skokie, IL 60077

Reason:  “Rexall Earache Relief Drops”, “Kids Relief Earache”, and “Auro Earache Relief Ear Drops”  “Murine Eardrops for Earache Relief” and “TopCare Earache Relief Ear Drops” are prescription drugs within the meaning of Section 503(b)(1) of the Act because it is intended to treat diseases that requires diagnosis and treatment by a physician or is intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Ear pain (earache) is not a currently recognized OTC indication in the final monograph for topical otic drug products (21 CFR 344) or in any approved OTC new drug application.

Issued to Brower Enterprises, 1002 E. Fifth Street, Canton, South Dakota 57013.  Reason: During an inspection of your facility our investigators found significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations, found in 21 CFR 111. These violations cause your products Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.

Issued to Pure Energy Products, Inc., 6409 S Western Avenue, Oklahoma City, OK 73139.  Reason:  During the inspection, our investigator noted that you distribute obestrim, which declares 1,3-dimethylamylamine as a dietary ingredient. This ingredient is also called, among other names, dimethylamylamine, DMAA or methylhexanamine, and will be referred to in the rest of this letter as “dimethylamylamine”.  As explained below, dimethylamylamine is not a dietary ingredient. Rather, it is an unsafe food additive that causes your dimethylamylamine-containing product to be adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(i)] because it is a food to which dimethylamylamine, a drug approved under section 505 of the Act [21 U.S.C. § 355], has been added. 

Issued to Y.S. Health Corp, 411 Kingston Court, Mt. Prospect, IL 60056.  During a recent inspection serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111) were found. These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(g)(1)], in that the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.  Unapproved new drug violations were also found (Arth 2000+ Cream).

Issued to GumRunners, LLC, 333 Washington Street, FL-2, Jersey City, NJ 07302.  Reason: Your products Spearmint Jolt Energy Gum, Icy Mint Jolt Energy Gum, and Mint Flurry Energy Mints, offered on your website are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].   Claims found are:  “Prevents Parkinson’s disease”, “Prevents skin cancer”, “Prevents dry-eye syndrome”,  “Helps control ADHD”, “Can help breathing in young babies”, and “Curbs Depression”.

Oct 16    Guidance for Industry All can be downloaded at: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

1)      Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071185.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

2)      Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions, Annex 14, Bacterial Endotoxins Test General Chapter.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM219167.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

3)      Q3D Elemental Impurities.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM371025.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Oct 10    Resolved Drug Shortages – Tamiflu (oseltamivir) Oral Suspension 6 mg/mL produced by Genentech.

Oct 10    Public Notification: The following products contain a hidden drug ingredient: sibutramine:

“Bella Vi Insane Amp’d”, “Bella Vi Amp’d Up”, “Be Inspired”, “Dr. Mao Slimming Capsules”, “Perfect Body Solutions”, and “Burn 7”.  These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and can present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Oct 8      Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act were sent to Genzyme, Amedra Pharmaceuticals, The Medicines Company, Salix Pharmaceuticals, Sunovion Pharmaceuticals, Pfizer, and Nautilus Neurosciences.  Section 505B(d)(1) of the “Act” requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatric formulation. 

Oct 3      FDA approves Duavee to treat hot flashes and prevent osteoporosis.  The U.S. Food and Drug Administration today approved Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause.

Oct 3      Guidance for Industry

Comprehensive List of Guidance Documents (updated).  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079645.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

New/Revised/Withdrawn CDER Guidance:  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM254636.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Oct 2      FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning.  FDA has issued a Drug Safety Communication (or DSC) warning that an additional analysis shows an increased risk of death when intravenous (or IV) Tygacil (or tigecycline) is used for FDA-approved uses as well as for non-approved uses.  Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.

Oct 2      Guidance for Industry – Refuse to Receive Standards.  This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive the submission.   Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM370352.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Draft Guidance for Industry on Bioanalytical Method Validation.  This draft guidance is intended to provide recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics.  Download at:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format.   This draft guidance is intended to assist applicants with developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.  Download at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368602.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format.  This draft guidance is intended to assist applicants with developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368602.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Guidance for Industry on Electronic Source Data in Clinical Investigations.  This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.  This draft guidance document provides recommendations to sponsors on the parameters that should be routinely assessed in toxicology studies for INDs, NDAs, and BLAs. This draft guidance also discusses factors to consider in determining the need for additional studies to characterize potential endocrine disruptor properties of a drug.  Download at:  

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm369043.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Oct 1      The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.   Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mood changes and other symptoms that interfere with a person's ability to work, sleep, study, eat and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime, although some may experience a single occurrence.

Sep 30    FDA approves Perjeta for neoadjuvant breast cancer treatment.  The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.  Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease.

Recalls – Class II

IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.  Labeling: Incorrect or missing lot and/or expiry date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Sep 24    Public Workshop - Complex Issues in Developing Drug and Biological Products for Rare Diseases.  The purpose of the workshop is to discuss complex issues in clinical trials for developing drug and biological products (“drugs”) for rare diseases, including endpoint development and selection, use of surrogate endpoints and the accelerated approval pathway, clinical trial design, conduct and analysis, safety considerations, and dose selections; and to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases. FDA is seeking input on these topics from academic, clinical, and treating communities; patients and advocacy groups; industry; and government agencies.

Date: January 6-7, 2014   Time:  8:00 a.m. to 5:00 p.m.    Location:     FDA White Oak Campus, 10903 New Hampshire Ave,
Bldg. 31, Room 1503 (Great Room), Silver Spring, Maryland 20993

To read the agenda go to:  http://www.fda.gov/downloads/Drugs/NewsEvents/UCM370418.pdf

Sep 24       FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death.  Fentanyl patches are dangerous even after they’ve been used because they still contain high amounts of strong narcotic pain medicine.  Used fentanyl patches require proper disposal after use―fold the patch, sticky sides together, and flush it down the toilet right away.

Sep 20    FDA/CDER Small Business Chronicles.  This month’s issue is entitled “Safety Labeling Changes for Prescription Drugs”.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM369229.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery  You can find more information in the guidance located at:     http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM250783.pdf        

Sep 18    Federal judge approves consent decree against Shamrock Medical Solutions Group.   A Federal Judge has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.  Shamrock Medical repackages and distributes solid and liquid oral non-sterile drug products for human use to hospitals throughout the country. Recent FDA inspections found several violations at the facility, including failure by the quality control unit to fully follow its own quality control procedures and to examine packaged and labeled products to ensure correct labeling. The FDA has previously sent warning letters to Shamrock Medical for violating current good manufacturing practices (CGMP) and distributing incorrectly labeled drugs.  

Sep 18   Guidance for Industry

Patient Counseling Information Section of Labeling for Human Drug and Biological Products – Content and Format.   To download a copy go to: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368602.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Electronic Source Data in Clinical Investigations.    Download at: http://www.fda.gov/downloads/Dru, g, s/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Sep 16    FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert.  The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP).  Under the decree, Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility and introducing drugs into interstate commerce, including into the United States, from the Mohali facility until the firm’s methods, facilities, and controls used to manufacture drugs at the Mohali facility are established, operated, and administered in compliance with CGMP. 

Sep 16    Video Game Training Improves Cognitive Control in Older Adults.  Researchers found that seniors who play a 3-D video game improve their ability to sustain focus and multitask successfully. The results highlight the potential of the aging brain to improve certain skills.  During multitask training, participants used a joystick to maintain a moving car in the center of a winding road while also responding to road signs that popped up. As participants improved, the games got harder.  Seniors who played the multitasking game on a laptop at home for 1 hour a day, 3 times a week for 4 weeks (12 hours of total training) significantly improved their multitasking performance index at the end of the training period.

Sep 12    FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines.  OnabotulinumtoxinA is the only FDA approved drug treatment option for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults.

Sep 11    Guidance for Industry

Generic User Fee Amendments of 2012: Questions and Answers.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316671.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Guidance for Clinical Investigators, Sponsors, and IRBs – INDs Determining Whether Human Research Studies Can Be Conducted Without an IND.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Sep 10    Leiter's Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots 
Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor.
   The following products and lot numbers are subject to the nationwide recall:

·               Bevacizumab Lot No. 08052013@1, expiry 11/03/13

·               Bevacizumab Lot No. 08052013@4, expiry 11/03/13

·               Lidocaine/phenylephrine Lot No. 07302013@6, expiry 10/28/13

The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.

Sep 10    FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics.  The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.

Sep 10    Fee for Using a Priority Review Voucher in Fiscal Year 2014.  FDA is announcing the fee for using a tropical disease priority review voucher for fiscal year (FY) 2014 of $2,325,000.  Read more in the Federal Register here:  https://www.federalregister.gov/articles/2013/09/05/2013-21542/fee-for-using-a-priority-review-voucher-in-fiscal-year-2014?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Sep 10    Autism Spectrum Disorder now affects about 1 in 88 children.  Read more at:  http://newsinhealth.nih.gov/issue/Sep2013/Feature1

Sep 6      McNeil Consumer Healthcare Announces Voluntary Recall of Three Lots of Concentrated MOTRIN Infants Drops Original Berry Flavor 1/2 fluid ounce.  After releasing these three lots of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fluid ounce into the market, tiny plastic particles (approximately 1 mm in size or about the size of a poppy seed) were identified in a different product lot produced using the same batch of active ingredient, ibuprofen, during manufacturing.  The recalled lots are DCB3T01, DDB4R01, and DDB4S01.

Sep 5      Guidance for Industry

Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (Draft).   This guidance can be downloaded from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM367199.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

ANDAs: Stability Testing of Drug Substances and Products Q&A.  Copies available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Aug 23   Announcements

Secure Supply Chain Pilot Program (SSCPP).  The SSCPP is intended to assist the FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks.  The FDA will be accepting applications for participation in the SSCPP beginning September 16, 2013 and until December 31, 2013.  To read the Federal Register announcement go to:  http://www.gpo.gov/fdsys/pkg/FR-2013-08-20/pdf/2013-20215.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidance. This initiative at CDER will involve the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidance should be withdrawn, revised, or finalized with only minor changes.  There is more to read in the Federal Register notice located at:   http://www.gpo.gov/fdsys/pkg/FR-2013-08-07/pdf/2013-19051.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery    

Aug 21   Recalls – Class III

Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20.  Reason: Labeling: Missing Label; missing label on blister card.

buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01. Reason:  Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

Aug 21   Recalls – Class II

Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b) Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34.  Reason:  Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.

Rifadin (rifampin) capsules, USP, 150 mg, 100-ct capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc, Laval, Quebec, Canada H7L4A8, DIN # 02091887 Reason: Subpotent Drug: During review of retain samples the mnfr observed low fill in some capsules which was related to an issue detected with the encapsulating equipment.

Aug 16   Herbal Give Care LLC Issues Voluntary Nationwide Recall of Esbelder Man Capsules, Esbelder Fem Capsules, and Esbelder Siloutte Capsules Vitamin Supplements Due to Potential Health Risks.

Grand Prairie, Texas, Herbal Give Care LLC is voluntarily recalling all lots of Esbelder man (30 capsules), Esbelder fem (30 capsules) and Esbelder silhouette (30 capsules) to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine.  These products may pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Specialty Pharma Newsletter - July-Aug 2013 

Aug 18   Aidapak Services LLC Initiates Voluntary Recall of Selected Pharmaceuticals Repackaged by Aidapak Services LLC Due to Potential Incorrect Labeling.  Aidapak Services LLC is conducting a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in the States of Washington, Oregon, California, and Arizona for products listed on the company’s website. The Firm voluntarily recalled these products to the hospital/user level after learning of possible incorrect labeling which could involve OTC, prescription, and dietary supplement products.  All products affected by this recall are stamped with AidaPak’s packaging stamp. Products not stamped with AidaPak’s packaging stamp are not affected by this recall.                                             

Aug 15   FDA Requires Label Changes to Warn of Risk for Possibly Permanent Nerve Damage From Antibacterial Fluoroquinolone Drugs Taken by Mouth or by Injection.  The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.  Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).  The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.  Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position.  It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent.  Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away.

Aug 15   Specialty Compounding, LLC is voluntarily recalling all lots of sterile medications within expiry. Note: An earlier version of this news release indicated that the recall applied to all unexpired sterile compounded products dispensed since May 9, 2013; however, the recall applies to any sterile medication that has not reached its expiration date, including all strengths and dosage forms.  The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding.  There is a potential association between the infections and the medication at this time.  No calcium gluconate was shipped outside of the State of Texas.

Aug 15   FDA Small Business REdI Conference Fall 2013 – Registration now OPEN.  The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations.   It will be held September 25-26 at the Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD.   This event is FREE!   Register at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm364584.htm?source=govdelivery

Aug 14   Recalls – Class I   

Reumofan Plus, 30-count tablets per bottle.  Distributed by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico. Reason for Recall:  Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.  Distributed nationwide through Internet sales

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle.  Manufactured by: Cadila healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10                Reason for Recall:  Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

Aug 14   Recalls – Class II

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg & Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages.  Distributed by Novartis Consumer Health, Inc, Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.

Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches.   Distributed by Novartis Consumer health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging does not have NDC numbers.

No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch.   Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02  Reason for Recalls:  Defective container: products are packaged in pouches which may not have been fully sealed.              

Recalls – Class III

Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only,   Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36. Reason for Recall:  Contraceptive tablets out of sequence in Lots: LF01643C, LF01644C, Exp 7/14

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only.  Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. Reason for Recall:  Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Aug 14   Warning Letters

Issued to James G. Dina, Owner, Natural Products Services, Inc, 620 S. Andreasen Dr, Escondido, CA, 92029. Reasons: 1. Unapproved New Drugs 2. Adulterated Dietary Supplements (lack of identity testing and failure to establish product specifications).

Issued to Robert Occhifinto, President/Owner, N.V.E. Pharmaceuticals, Inc., 15 Whitehall Road, Andover, New Jersey 07821.  Reasons:  1. Failed to establish required specifications for stages in their manufacturing processes where control is necessary to ensure the quality of the dietary supplements produced, 2. Failed to establish component specifications and product specifications, 3. Failure to test products and components for conformity to specifications.

Aug 9     OPDP Enforcement Actions Webinar – October 28, 2013 at 10:30 AM.   The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) invites you to participate in the next Enforcement Webinar on October 28, 2013, from 10:30 AM to 11:00 AM (ET). Viewers can begin submitting questions 30 minutes prior to the webinar start time. During the webinar, OPDP will give stakeholders a chance to directly communicate with the Agency about clarifications or questions concerning recent Warning Letters and Untitled Letters issued by OPDP. This particular webinar will cover Warning Letters and Untitled Letters issued from July 2013 through September 2013.   To join the meeting as a guest:   https://collaboration.fda.gov/opdp1028

Aug 7     Recalls – Class I

Night Bullet Capsules, supplied in 1 ct packets, produced by Green Planet Inc, Riverside, CA  Reason for Recall:  Mrktd Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.

Aug 7     Recalls – Class II

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only.  Manufactured by VistaPharm, Inc., Birmingham, AL 35242.  Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA.    Reason for Recall:  Failed Impurity/Degradation Specification; "Related Compound C".

Enablex (darifenacin) Extended Release Tablet, 15 mg per tab. Physician Sample 7 Tablets bottle, Rx only.  Mnfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07.  Reason for Recall: Failed Impurities/Degradation Specifications: unspecified degradation product.

Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only.   Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. Reason for Recall:  Presence of Foreign Substance: The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg & phenylephrine HCl 5 mg) Liquicaps & NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg & phenylephrine HCl 5 mg) Liquicaps Combopack, each 48-ct Liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps & 16 NyQuil Sinex NightTime Liquicaps per carton. Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1. Reason for Recall:  Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed Liquicaps within the blisters.

Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Manufactured for: Prasco Laboratories, Mason OH, 45040, USA.   Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30    Reason for Recall:  Defective Container; this action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.

Aug 7     Health and Beyond LLC Issues Voluntary Nationwide Recall of Tranquility Product Due to Product Having Traces of Pharmaceutical Ingredients.  The products have been found to contain a trace of Doxepin which is a pharmaceutical for sleep and Chlorpromazine for psychotic disorders.  The product is used as a sleep product and is packaged in a white bottle with 30 pills per bottle with lot # 36678 and 36680.  The affected product in the Tranquility lots includes the following expiration date 9/15.  The product was distributed Nationwide, wholesale, retail and via internet.

Aug 6     Guidance for Industry.  Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.  You can obtain a copy at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf?source=govdelivery

Aug 5     Discontinued Tablets – Asenapine (Saphris) Unflavored tablets.  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., has announced that all unflavored tablets will be discontinued.  The Saphris black cherry flavor tablets will remain available.

Aug 5     FDA Announces Fiscal Year 2014 Generic Drug Fees.   As expected the fiscal year 2014 user fees will include an increase over the 2013 fees.  In the first year of the program (2013), the total revenue included a one-time fee for applications pending as of October 1, 2012. With this one-time fee removed from the calculation, the remaining fees make up the total revenue, which resulted in the increase. Additional factors, including the number of facilities that self-identify under GDUFA, are also used in calculating the facility fee.  The domestic facility fee will be $220,152; the ANDA fee will be $63,860; Prior Approval Supplement (PAS) Fee will be $31,930, and the Drug Master File (DMF) fee will be $31,460.  For further details go to:  http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18625.pdf

Aug 5     FDA Announces Fiscal Year 2014 Prescription Drug User Fees (PDUFA).  Application (with clinical data) fees will be $2,169,000.  Application (without clinical data) fees or a supplement with clinical data will cost $1,084,550.  Establishment fees are $554,600 and product fees are $104,060.  Learn more at:  https://www.federalregister.gov/articles/2013/08/02/2013-18624/prescription-drug-user-fee-rates-for-fiscal-year-2014?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov 

Aug 5     Guidance for Industry:  Safety Labeling Changes – Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.   Learn more at:  http://www.gpo.gov/fdsys/pkg/FR-2013-07-30/pdf/2013-18236.pdf?source=govdelivery

Aug 3     CTV Best Group Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Best Slim 40 Pills Lot # 109400 Expiry Dec. 31, 2016, because of Potential Health Risk.   Testing by the U.S. Food and Drug Administration (“FDA”) revealed the presence of “sibutramine” in Best Slim.  Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

Aug 1     FD Safety Podcast:  FDA Warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen.  On August 1, 2013, the FDA issued a Drug Safety Communication informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens- Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen.  Anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away.  Listen to the podcast at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm363918.htm?source=govdelivery

Jul 31     Southfield, MI, Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level. There is a question of sterility assurance for the affected products raised by the FDA.  To see the list go to:  http://www.fda.gov/Safety/Recalls/ucm363284.htm?source=govdelivery

 Jul 31     Recalls – Class II

Diclofenac Sodium & Misoprostol Delayed-Release Tabs, 75mg/0.2mg, 60-ct bottle, Rx only. Manufactured by Watson Labs, Inc., Corona, CA 92880, NDC 0591-0398-60. Reason for Recall:  Failed Tablet/Capsule Specifications: Broken tablets.

Jul 31    Recalls – Class III

Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a) 100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only.   Manufactured by Watson Laboratories, Inc., Corona, CA92880.  Reason for Recall:  Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

Jul 29     Drug Information Update - FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement.  The U.S. Food and Drug Administration has issued a Press Announcement warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.  The FDA has received reports of 29 adverse incidents associated with the use of Healthy Life Chemistry By Purity First B-50.  These reports include fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels.  Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone. 

Jul 26     FDA Drug Safety Podcast: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems.  Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.  Serious liver damage has occurred in patients receiving high doses of Nizoral for short periods of time as well as those receiving low doses for long periods.

Jul 24     Notice to Industry: FDA Issues Draft Guidance for Pre-Launch Importation Requests (PLAIR).  This draft guidance to industry, outlines the agency’s policy on the importation of unapproved finished drug products in anticipation of approval and market launch of a pending new drug application (NDA), abbreviated new drug application (ANDA) or biologics licensing application (BLA) regulated by FDA’s Center for Drug Evaluation and Research (CDER).  You can read the Federal Register Notice at: https://www.federalregister.gov/articles/2013/07/24/2013-17768/draft-guidance-for-industry-on-pre-launch-activities-importation-requests-av,, ailability 

Jul 23     FDA alerts consumers of undeclared drug ingredients in over-the-counter diabetes product.  The U.S. Food and Drug Administration is advising consumers not to purchase or use “Jiang Tang Yi Huo Su Jiao Nang,” a drug product promoted and sold as a diabetes treatment. The product contains three active pharmaceutical ingredients, including one that was removed from the U.S. market because of the risk of serious side effects.  FDA laboratory analysis found that “Jiang Tang Yi Huo Su Jiao Nang” contains the following undeclared potentially harmful active ingredients: glyburide, metformin, and phenformin.  Read more at:  http://www.fda.gov/Drugs/DrugSafety/ucm361618.htm?source=govdelivery

Jul 23     Herbal Give Care LLC Issues Voluntary Nationwide Recall of Esbelin Siloutte Te and Esbelin Siloutte Vitamin Supplement Due to Potential Health Risks.   Grand Prairie, Texas, Herbal Give Care LLC is voluntarily recalling all lots of Esbelin Siloutte Te and Esbelin Siloutte Herbal Blend with L-Carnitine (30 Capsules), to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine.   Because of this, these products may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. 

Jul 22     Volcano Company, Issues Voluntary Worldwide/Nationwide Recall of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules, Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients.  Long Beach, CA, Volcano Company is voluntarily recalling all lots of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules to the consumer level. FDA test results revealed the Volcano Male Enhancement Liquid has been found to contain undeclared Desmethyl Carbodenafil, Dimethylsildenafil, and Dapoxetine.

Jul 18     FDA/CDER Small Business Chronicles – The USP Salt Policy.  You can download a copy at:     http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM360816.pdf?source=govdelivery

Jul 15     Hardmenstore.com Issues Voluntary Nationwide Recall of Silver Sword and Clalis at the Request of the FDA.  Upon request of the FDA, Hardmenstore.com is voluntarily recalling 430 lots of Silver Sword & Clalis at the consumer level. According to reps of the FDA, Silver Sword and Clalis have reportedly been found to contain amounts of PDE-5 Inhibitor Sildenafil, which could cause adverse reactions and drug interactions normally associated with the active ingredient in Viagra.

Jul 12     Drug Information Update - FDA approves new treatment for a type of late-stage lung cancer.   The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.  Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Gilotrif is being approved concurrently with the Therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations.

 Jul 10     Recalls – Class III

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tabs 0.625 mg/2.5 mg, 1 blister card containing 28 tabs, Rx only & Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tabs 0.625 mg/5.0 mg, 1 blister card containing 28 tabs, Rx only.   Manufactured by Wyeth Pharmaceuticals Inc., Philadelphia, PA. Reason for Recall:  Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.

 Jul 9       Draft Guidance for Industry – Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM359184.pdf?source=govdelivery 

Jul 7       Recalls – Class II

INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic.   Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com. Reason for Recall:  Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug. 

Jul 5       Sandoz US Announces Voluntary Nationwide Recall of Estarylla.  Princeton, New Jersey, – Sandoz is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US, following a customer report of a placebo tablet present in a row of active tablets on one pack. Estarylla is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. 

Jul 3       The Rhode Island Department of Health (HEALTH) advises consumers not to eat Mediterranean Olives.  Specifically, Calcidica Sweet (Brand: Bel Frantoio) sold at any Ocean State Job Lot (OSJL) stores. OSJL is voluntarily recalling the product after HEALTH staff discovered that these products were not handled appropriately to prevent production of the toxin that causes botulism.

Jul 1       FDA approves the first non-hormonal treatment for hot flashes associated with menopause.   The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.  There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.  Hot flashes associated with menopause occur in up to 75 percent of women and can persist for up to five years, or even longer in some women. Hot flashes are not life-threatening, but the symptoms can be very bothersome, causing discomfort, embarrassment and disruption of sleep.     

 

Specialty Pharma Newsletter - May-June 2013 

June 28  Voluntary Recall of JaDera and Xiyouji Qingzhi Weight Loss Supplements.  Miami, Florida, Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi” Weight Loss Supplement. These product have been found to contain undeclared Sibutramine.  Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

June 28  Office of Compliance (OC) and Center for Drug Evaluation and Research (CDER), are excited to announce their first Virtual Hiring Event. You will have the opportunity to meet the Director along with other staff members and learn firsthand about the positions available within OC.  FDA is looking for candidates in the areas of Chemical Engineering, Chemistry, Biology, Microbiology, Pharmacology, Pharmacy, Regulatory Counsel, Consumer Safety Officers and Project Managers. To register for this event, please go the following link:  www.fda.gov/gdufahiring  The recorded hiring event will be available for viewing for those participants who register, but are unable to attend the event live.  OC encourages all interested candidates to register in advance of the event for consideration.

June 28  Public Notification: “Silver sword” “Strawberry Balance” and “Meizi Evolution” Contain Hidden Drug Ingredients.  These products are promoted and sold for sexual enhancement on various websites and in some retail stores.  FDA laboratory analysis confirmed that Silver sword contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED).   FDA laboratory analysis confirmed that “Strawberry Balance” and Meizi Evolution contain sibutramine.  Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.  Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

June 27  The USDA Food Safety and Inspection Service has issued a compliance guide that may be helpful to other industries as well.  FSIS is issuing this guidance document to provide criteria to establishments producing meat, poultry, and processed egg products for selecting a commercial or private microbiological testing laboratory to analyze establishment samples.  To download, go to:  http://www.fsis.usda.gov/wps/wcm/connect/464a4827-0c9a-4268-8651-b417bb6bba51/Guidance-Selection-Commercial-Private-Microbiological-Testing-lab-062013.pdf?MOD=AJPERES 

June 26  Recalls – Drugs – Class III

Sodium Sulfacetaminde 10% and Sulfur 5% Lotion (NDC 42792-102-01).  Manufactured for Austin Pharmaceuticals, LLC, Wilmington, Delaware, by Mission Pharmacal Company has been recalled because the drug product active ingredients were formulated incorrectly (Super potent) with respect to the labeled strength.

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only (NDC 50383-796-16).    This product was manufactured by Hi-Tech Pharmacal Company Inc., Amityville, NY.  It has been recalled because it failed stability at 24 months (Sub potent).

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only. This product was distributed by G.D. Searle LLC, Division of Pfizer Inc., New York, NY 10017.  It has been recalled because it failed dissolution specification.

Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g).  It was manufactured by Faria Limited LLC dba Sheffield Pharmaceuticals. It is being recalled because it failed stability specifications; unable to meet shelf life exp date.

 Recalls – Drugs – Class II

Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a) Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only.   The product was manufactured for Teva Pharmaceuticals by Cephalon, Inc., Salt Lake City, UT 84116.  Product is being recalled due to an out of specification dissolution result (sub-potent drug) during stability testing.

 

 

 

       

June 26 Guidance for Industry

Draft Guidance for industry: Expedited Programs for Serious Conditions--Drugs & BiologicsThe draft guidance will also provide a single source for information on these programs for industry.  In addition, the draft guidance aligns CDER’s criteria for priority review designation with CBER’s criteria (i.e., only products intended to treat a serious condition are eligible for priority review, unless otherwise eligible under specific statutory provisions).  You can obtain a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf?source=govdelivery

Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.  The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.'' This guidance was initially published as draft guidance on February 13, 2012. The draft was revised to clarify FDA's expectations and recommendations and to include references to a recently-developed assay for detecting ruminant contamination of crude heparin.  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291390.pdf?source=govdelivery

Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products.  The Food and Drug Administration is announcing the availability of a guidance entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonization (ICH) guidance Q1A (R2) through Q1E.  The use of these ICH recommendations will standardize FDA's stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient.   Get your copy at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072873.pdf?source=govdelivery

Guidance for Industry: Co-development of Two or More New Investigational Drugs for Use in Combination.  This guidance is intended to assist sponsors in the co-development of two or more investigational drugs that have not been previously developed for any indication (i.e., ``new investigational drugs'') to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during co-development of two or more new investigational drugs.  It is not intended to apply to development of combinations of already approved drugs or to development of a single new investigational drug to be used in combination with an already approved drug or drugs. The guidance is not intended to apply to biological products regulated by the Center for Biologics Evaluation and Research or medical devices.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf?source=govdelivery      

June 26  Warning Letters

A Warning Letter Was Issued to Eva Pharmacy (support@customersupportglobal.com; VisitSupportPage@hotmail.com; Jennaiyyek@hotmail.com; viviyanrydky@hotmail.com.)   After reviewing their websites, the FDA determined that their websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Specifically, these products are new drugs within the meaning of FD&C Act and are not recognized as safe and effective and consequently are “Misbranded and Unapproved Drugs”.

June 21 Drug Information Update - FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers.  The U.S. Food and Drug Administration announced today that the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.  Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices.  To avoid that burden for companies, the FDA filed a formal “listing request” with the EC in January 2013 that the FDA’s good manufacturing practices be considered at least equivalent to those in Europe.

June 20  Sage Pharmaceuticals, Inc., Shreveport, Louisiana, has been cited for violation of the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing unapproved and misbranded drug products.  This is the second injunctive case that the government has brought against Sage alleging the distribution of unapproved new drugs.  In 2000, the government obtained an injunction against the company banning the manufacture and distribution of two unapproved new drugs.  Since that time, FDA inspections revealed that defendants continue to manufacture and distribute other drug products—including prescription pain relievers, over-the-counter (OTC) cough and cold remedies, and OTC wound cleansers—without first obtaining the requisite FDA approvals.  As a result, the defendants’ products are unapproved new drugs and misbranded drugs under the FDCA, and potentially unsafe and ineffective.   The Justice Department will seek a permanent injunction requiring the defendants to cease all receiving, processing, manufacturing, preparing, packaging, labeling, holding, and distributing activities until they comply with applicable FDA regulations.  

June 20  Beta Labs, LTD Announces a Recall of Dietary Supplements Oxyphen, Phentalene, Phen FX, and Red Vipers Due to Possible Health Risk.  The recall was initiated on June 15, 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA.  The UPC codes for each of the products are: Oxyphen XR, 70541 59974; Phentalene, 70541 59982; Phen FX, 29882 55980; Red Vipers, 29882 55981. The Products are all in capsule form. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health.  Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.             

June 19  Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tabs. The recall was first initiated on Jun 17, 2013, after a complaint was received concerning a bottle labeled as Enteric Coated Aspirin Tabs, 81 mg, actually containing Acetaminophen 500 mg tabs.  Consumers may be inadvertently taking Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage to those who take other drugs containing acetaminophen, consumers who take 3 or more alcoholic drinks every day or those who have liver disease. The labeled directions instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of Acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg)!  The lot was manufactured and packaged by Advance Pharmaceutical Inc., Holtsville, NY, under the label of Rugby Laboratories, Inc., Duluth, Georgia 30097. 

June 19  Recalls – Drugs – Class I  

Rugby Natural Iron Supplement Ferrous Sulfate, 5 gr (325 mg), 100 Tabs.  Manufactured for: Rugby Laboratories, Inc., Duluth, Georgia 30097.  Manufactured by Advance Pharmaceutical, Inc., Holtsville, Georgia (UPC 0 0536-5890-013).  Reason: Labeling; Label Mix-up; bottles of Ferrous Sulfate actually contain Meclizine Hydrochloride (indicated for motion sickness).

June 19  Recalls – Drugs – Class III                                                                                                            

Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL).  Manufactured by Teva Pharmaceuticals USA, Inc., Sellersville, PA.  Reason for recall:  Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.                 

June 18    FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate).  The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).  Both patients were found to have very high olanzapine blood levels after death. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.

June 12  Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets.  Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.  The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

June 11  Guidance for industry: “Contract Manufacturing Arrangements for Drugs: “Quality Agreements”.  This guidance describes FDA’s current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to current Good Manufacturing Practice (cGMP). In particular, the guidance describes how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf?source=govdelivery

June 11 Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs Under an Investigational New Drug Application – Questions and Answers Guidance Documents.  FDA has made available two draft guidance for industry entitled, “Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers,” and “Charging for Investigational Drugs Under an Investigational New Drug Application – Questions and Answers.”  These two guidance documents are intended to provide information about certain aspects of regulations on expanded access to investigational drugs for treatment use, and to provide information on the agency’s regulation on charging for an investigational drug under an investigational new drug application. The Expanded Access document can be found at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351261.pdf?source=govdelivery  The Charging for Investigational Drugs document can be found at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351264.pdf?source=govdelivery

June 11  Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment.  This guidance outlines FDA's current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It also addresses additional considerations for drug products developed as drug-device combination products. This guidance revises the guidance for industry entitled “Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),” published in February 1999.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM354468.pdf?source=govdelivery

June 5    Recalls – Drugs – Class II                                                                                                                                Ropinirole hydrochloride tablets, USP 4 mg, 100-ct bottle (NDC 0378-5504-01), Rx only. Manufactured for Mylan Pharmaceuticals, Inc, Morgantown, WV 26505 USA  Made in India.  Reason for recall: Labeling - Label Error on Declared Strength - Unopened bottles of Ropinirole USP 3 mg tabs was found to be incorrectly labeled as Ropinirole USP 4 mg tabs.     

June 5    Recalls – Drugs – Class III                                                                                                                            Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01.   Manufactured for Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810.  Manufactured by Aurobindo Pharma Limited, Hyderabad- 500 072 India.  Reason for recall: Labeling - Label Error on Declared Strength - Incorrect strength on side display panel of label.

June 5    Guidance for Industry:  Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.  You can obtain a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf?source=govdelivery  

June 3    FDA Drug Safety Podcast: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies.  Magnesium sulfate is approved to prevent seizures in preeclampsia, a condition in which the pregnant woman develops high blood pressure and protein in the urine, and for control of seizures in eclampsia.  Preeclampsia can lead to eclampsia, seizures, stroke, multiple organ failure, and death of the woman and/or baby.  Use of magnesium sulfate injection to pregnant women longer than 5 to 7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones, called osteopenia, and bone breaks, called fractures.  The shortest duration of treatment that can result in harm to the baby is not known.   A podcast on this subject is available at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm354762.htm?source=govdelivery

May 30  FDA announces import of injectable nutrition drugs.  This action addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.  The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.  TPN is an intravenous food solution containing several drugs that have been in short supply, including  trace elements, potassium phosphate, and sodium phosphate. Hospitals nationwide rely on TPN.  "While we have made progress on the critical issue of drug shortages, we remain extremely concerned about all current and potential drug shortages, and we are vigilant in our efforts so patients have access to the medicines they need, when they need them,” said FDA Commissioner Margaret A. Hamburg, M.D.  The FDA is exercising regulatory discretion for Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., to import trace elements and phosphate injection from its Norway plant so the drugs can reach Americans in need.  The shortages are largely the result of a decision by American Regent/Luitpold, a large manufacturer of TPN products, to temporarily shut down at the end of 2012.

May 30  MRSA study: simple steps slash deadly infections in sic, ,, kest hospital patients.  A new study on antibiotic-resistant bacteria in hospitals shows that using germ-killing soap and ointment on all intensive-care unit (ICU) patients reduced bloodstream infections by up to 44 percent in 74,000 patients and significantly reduced the presence of methicillin-resistant Staphylococcus aureus (MRSA). Patients who have MRSA present on their bodies are at increased risk of developing a MRSA infection and can spread the germ to other patients.

May 29  Recalls – Class II                                                                                                                            

Numerous lots of levothyroxine sodium tablets at various strengths (approximately 30 items) are being recalled.  The tablets were manufactured for Forest Pharmaceuticals, Inc., St Louis, Missouri, by Lloyd Pharmaceutical, Shenandoah, Iowa.  Reason for recall: cGMP deviations.  After a quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only are being recalled.  They were manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV 26505, and packaged and distributed by UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.  The recalling firm is Mylan Institutional, Inc., d.b.a. UDL Laboratories.

May 29    FDA approves two drugs, companion diagnostic test for advanced skin cancer. The U.S. Food & Drug Administration today approved two new drugs, Tafinlar (dabrafenib) & Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer. Melanoma is the leading cause of death from skin disease. The National Cancer Institute estimates 76,690 Americans will be diagnosed with melanoma & 9,480 will die from the disease. The most serious side effects reported in patients receiving Tafinlar included an increased risk of skin cancer (cutaneous squamous cell carcinoma), fevers that may be complicated by hypotension (low blood pressure), severe rigors (shaking chills), dehydration, kidney failure & increased blood sugar levels requiring changes in diabetes medication or the need to start medicines to control diabetes. The most common side effects reported in patients receiving Tafinlar included thickening of the skin (hyperkeratosis), headache, fever, joint pain, non-cancerous skin tumors, hair loss & hand-foot syndrome.  The most serious side effects reported in patients receiving Mekinist included heart failure, lung inflammation, skin infections & loss of vision. Common side effects included rash, diarrhea, tissue swelling (peripheral edema) and skin breakouts that resemble acne.

May 28  Guidance for Industry:  Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in ICH Regions Annex 13 Bulk Density and Tapped Density of Powders General Chapter.   Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM218825.pdf

May 21  DA/CDER Small Business Chronicles – BsUFA.  The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Biosimilar User Fee Act of 2012 (BsUFA).  In this issue, FDA discusses the background of BsUFA, performance goals, and associated fees.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM353388.pdf?source=govdelivery

May 15  FDA approves Simponi to treat ulcerative colitis.  The U.S. Food & Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.  Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory & immune responses.  Previously approved to treat rheumatoid arthritis, psoriatic arthritis & ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.  Ulcerative colitis is a chronic disease that affects about 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease.

May 15  Recall –Drugs – Class III

Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle.  Distributed by Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01.  Manufactured by L. Perrigo Company, Allegan, Michigan.  Reason:  Failed Impurities/Degradation Specifications: Perrigo is conducting a wholesale level recall of two batches of this product due to an out of specification impurity result during three month stability testing.

May 15  The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.  Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.

May 14  FDA approves Nymalize—first nimodipine oral solution for use in certain brain hemorrhage patients.  New oral formulation may help reduce potentially fatal medication errors.  On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.  “Having an oral version of this product may help reduce the medication errors we’ve seen from erroneous intravenous administration of the contents of oral capsules,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Nymalize is a liquid that is administered orally, or via nasogastric tube or gastric tube, and there is no need for a needle to be used, which is what caused past medication errors.”

May 9    Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors.  The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance focuses on safety aspects of the container label and carton labeling design, and provides a set of principles and recommendations for ensuring that critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.   Download your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf?source=govdelivery

May 8    Recall – Drugs – Class III

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only,

Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19),

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle (NDC#: 0430-0544-23),

Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738.  Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866.  Reason for recall - Chemical contamination - Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

May 7    Public Notification: FDA is Advising Consumers Not To Purchase Vicerex, Bullet Proof, and Lightning Rod.  FDA Laboratory analysis confirmed that these products contain tadalafil, the active ingredient in the FDA-approved prescription drug Cialis, used to treat Erectile Dysfunction (ED).  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

May 2    Recalls – Drugs – Class II

Gilmepiride Tablets, USP, 2 mg, 100-count tablets per bottle, Rx only.   Manufactured for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.  Reason for recall - Failed Tablet/Capsule Specifications - One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

Apr 25   Public Notification:  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Sex Plus,” a product promoted and sold for sexual enhancement on various websites and in some retail stores.  FDA laboratory analysis confirmed that “Sex Plus” contains undeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil. Sulfosildenafil and dimethylacetildenafil are structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED).  Tadalafil is the active ingredient in Cialis, also an FDA approved prescription drug for ED.  These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

Public Notification:  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Zoom-Zooma-Zoom,” a product promoted and sold for sexual enhancement on various websites and which may be sold in retail stores.  FDA laboratory analysis confirmed that “Zoom-Zooma-Zoom” contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat Erectile Dysfunction (ED).  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

 Apr 24   Recalls – Drugs – Class II

Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62).  Packaged by Precision Dose, Inc., S. Beloit, IL 61080.  Reason for recall: Labeling - Not Elsewhere Classified. This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

Levoxyl (levothyroxine sodium) tablets, USP. 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg packaged in 100-count bottles and/or 1000 count bottles, Rx only. Manufactured and Distributed by King Pharmaceuticals, Inc., Bristol, TN 37620.  Recalling firm:  Pfizer, Inc., New York, NY.   Reason for recall - Chemical contamination - Emission of strong odor after package was opened.

 Apr 24   Recalls – Drugs – Class III

buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only.  Distributed by Actavis South Atlantic LLC, Sunrise, FL 33325.  Packaged by American Health Packaging, Columbus, OH 43217.  Reason for recall - Failed USP Dissolution Test Requirements  -  Out-of-specification dissolution results at the 8 hour stability testing point.

Apr 17   Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products.  This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use a drug product. This guidance finalizes the draft guidance issued on September 19, 2011.  To obtain a copy, go to:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM272122.pdf?source=govdelivery

Apr 16   FDA Actions on OxyContin Products.  FDA has determined that the reformulated version of OxyContin has abuse-deterrent properties and has approved new labeling that indicates that the product has physical and chemical properties that are expected to make abuse by injection difficult and to reduce abuse via the intranasal route.  FDA also has determined that Purdue Pharma’s original formulation of OxyContin was withdrawn from the market for safety reasons. As a result, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of these products. 

Apr 12   Affirm XL, Inc., Issues a Voluntary Nationwide Recall of Affirm XL Dietary Supplement Tablet, Lot 1190001 Due to Potential Health Risk.  Affirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for this product.

Apr 11   Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns.  Green Valley Drugs notified healthcare professionals and their organizations about the recall of all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. A full list of the recalled products (name, lot # and Beyond Use date) is linked from the press release or can be accessed at greenvalleymed.com.  Green Valley Drugs sterile products covered under this recall were distributed nationwide.  The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques. Green Valley has received no reports of injury or illness associated with the use of the products.  Until further notice, healthcare providers should stop using all lots of sterile products and return them to the company.

 Apr 10   Recalls – Drugs – Class II

Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only.  Distributed by Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807.  Recalling firm is Dr. Reddy’s Laboratories Tennessee, LLC.   Reason for recall: Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.

Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only.   Manufactured  for: Versapharm Incorporated, Marietta, GA; Manufactured by West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.  Reason for recall - Sub potent Drug - Out Of Specification results for assay at the stability time-point of 24 months.

Recalls – Drugs – Class III

Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only.  Manufactured by Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.  Reason for recall - Labeling Illegible - There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.

Apr 9     New web-based learning course-“Electronic Common Technical Document (eCTD): Overview and Submission”.  FDA/CDER’s Small Business Assistance Program announces the launch of its first CDERLearn web-based learning courses.   It will address the essential steps of submitting electronic submissions to CDER, and is a great resource for questions about the submission process.  Take the course at:  http://www.accessdata.fda.gov/scripts/cder/training/eCTD/index.htm?source=govdelivery

Specialty Pharma Newsletter - March 2013

Apr 8     “Childhood Immunization as a Tool to Address Health Disparities.”   This session will be available via live webcast from CDC headquarters in Atlanta, Georgia on Tuesday, April 16 at 1 p.m. (EDT) at http://www.cdc.gov/about/grand-rounds/.   This session of Grand Rounds will examine how immunization has helped reduce infectious disease disparities among U.S. children, reducing infectious disease burdens in children from racial/ethnic populations, and how immunization has, as a result, contributed to health equity.

Apr 4     Public Notifications “Ninja Mojo”, “Love Rider” and “Affirm XL” contain hidden drug ingredient.

All contain either tadalafil which is the active ingredient in Cialis or sildenafil which is the active ingredient in Viagra.  This undeclared may interact with nitrates which are found in some prescription drugs, such as nitroglycerin.  This interaction may lower blood pressure to dangerous levels.

Ninja Mojo was distributed by Ninja America Inc., College Point, NY.   Love Rider” was distributed by Nutratech, Inc., Woodbridge, VA.  “Affirm XL was distributed by Affirm XL, LLC, Ladera Beach, CA (made in Korea).

Apr 3     Recalls – Class II

Ciprofloxacin Tablets, USP, 500 mg, manufactured for West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan (NDC 01439928-01).  This product is being recalled due to the presence of foreign material (rubber-like material).

Apr 3     Guidance for Industry

CDER List of Guidance Documents can be viewed/downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079645.pdf?source=govdelivery

CDER List of New/Revised/Withdrawn Guidance (January 1, 2013 to April 1, 2013) can be viewed/downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM254636.pdf?source=govdelivery

Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format can be viewed/downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346564.pdf?source=govdelivery

Apr 2     Nicotine Replacement Therapy (NRT) Labels May Change.   FDA, after reviewing scientific research on the safety of NRT products sold over the counter (OTC)—has decided that some warnings and limitations specified in the directions for use on the labels of these products are no longer necessary to make sure they are used safely and effectively to quit smoking.  You can learn more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm345087.htm?source=govdelivery                 

Apr 2     Change of Address; Biologics License Applications.  FDA is amending CFR 600.2(b) to update the address for applicants to submit BLAs and BLA amendments and supplements regulated by CDER. The new address for all these submissions is CDER Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901B Ammendale Rd., Beltsville, MD 20705. This action is being taken to ensure accuracy and clarity in the Agency's regulations.  The federal register notice is available at:  https://www.federalregister.gov/articles/2013/04/02/2013-07578/change-of-address-biologics-license-applications-technical-amendment?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Apr 2    Draft Guidance for Industry                                                                                                               Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants.  This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the CDER and CBER. The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdf?source=govdelivery

Formal Dispute Resolution: Appeals Above the Division Level.  This guidance is intended to provide recommendations for industry on the procedures in CDER and CBER for resolving scientific and procedural disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented. This guidance revises the guidance of the same name issued in February 2000.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf?source=govdelivery

Apr 2     Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation.  This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or cutting a higher-strength tablet into smaller portions.) Specifically, this guidance recommends guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet; and nomenclature and labeling for approved scored tablets.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269921.pdf?source=govdelivery

Apr 1     The Electronic Drug Registration and Listing Instructions have been updated.  This and related links can be found at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm?source=govdelivery

Apr 1     Guidance for Industry

SUPAC: Manufacturing Equipment Addendum.  You can read or download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346049.pdf?source=govdelivery

Mar 29   FDA approves Invokana to treat type 2 diabetes.   First in a new class of diabetes drugs.  The U.S. Food and Drug Administration today approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.  Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels.  Invokana has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone, and insulin. Invokana should not be used to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); or in those with severe renal impairment, end stage renal disease, or in patients on dialysis.  Caution: new drugs in a new class of drugs may exhibit previously unknown side effects during their first five years on the market.

Mar 27   Recalls – Drugs Class III

Carisprodol Tablets, USP 350 mg Rx Only manufactured by West-Ward Pharmaceuticals, Eatontown, NJ.    This product is being recalled because this product was recently reclassified in June 2012 as C-IV, and it was not relabeled with the required “C-IV” imprint after that date.

Mar 27   Recalls – Drugs Class II

Meprobamate Tablets, USP, 400 mg and 200 mg, Rx Only manufactured by Watson Laboratories, Inc., Corona, CA 92800.   These products are being recalled because they failed impurities/degradation – out of specification result for the impurity diphenyl sulfone.

Zarah Drospirenone/Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg Rx Only, manufactured by Watson Laboratories, Inc., Corona, CA 92800.  This product is being recalled because it failed specification - tablets break when pushed through blister pack.

Mar 25   TOBI Podhaler (tobramycin inhalation powder) has been approved for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.  Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States. Cystic fibrosis causes the body to produce thick, sticky mucus that builds up in the lungs and blocks airways. The buildup of mucus makes it easy for bacteria like P. aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs. Man, y, patients with cystic fibrosis are treated with antibiotics using a nebulizer machine.  TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.

Mar 22  Warning Letter

Issued to Asada Milling Company, Ltd, Gunma, Japan 370-2202.  During inspection in October 2012 significant deviations from current Good Manufacturing Practice for the manufacture of active pharmaceutical ingredients (APIs) were identified.  Among them were failure to follow written procedures, failure to maintain and clean manufacturing equipment and facilities, and failure to establish written procedures pertaining to handling of raw materials used in API production and failure to establish specifications for finished API release, failure to prepare adequate batch production records and failure to identify produced batches with a unique batch identification number.     

Mar 19   Recalls – Class II

Clinical Specialties is voluntarily recalling Avastin unit dose syringes.  The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.  This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes.

Mar 18   FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey.  The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting, Inc., Tinton Falls, N.J., a specialty pharmacy licensed by the state of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.  Giving a patient a contaminated injectable drug can result in a life-threatening infection.  In addition to the recall, on March 15, 2013, the New Jersey State Board of Pharmacy entered into an Interim Voluntary Consent Order with Med Prep Consulting Inc. Under the Order, the firm has temporarily halted all production operations, including the processing and shipping of medications.

Mar 15   Drug Shortages                                                                                                                                

Rifamate capsules containing 300 mg rifampin and 150 mg isoniazid (NDC 0068-0509-60)  manufactured by Sanofi-aventis U.S. LLC., will not be available until July 2013 due to manufacturing delays.  

Levothyroxine sodium (Levoxyl) tabs in the 50 mcg - 200 mcg strengths are currently on back order by Pfizer.

Mar 15   FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.  The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.  FDA recommends that at this time, patients should (at their own risk) continue to take their medicine as directed until they talk to their health care professional, and health care professionals to make a determination to or not to continue to follow the prescribing recommendations in the drug labels.  

Mar 14   The Cumulative Supplement 2 (February 2013) for the Approved Drug Products (The Orange Book) is now available for download:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf?source=govdelivery       Orange Book Data Files (compressed) (ZIP 549KB) can be found at:  http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwMzE1LjE2NzEwNTMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDMxNS4xNjcxMDUzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MDU0NTQ1JmVtYWlsaWQ9cmVndWxhdG9yeW5ld3NAZ21haWwuY29tJnVzZXJpZD1yZWd1bGF0b3J5bmV3c0BnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&108&&&http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip?source=govdelivery

Mar 14   FDA/CDER Small Business Chronicles for March is entitled “Enrichment Strategies”.  You can download/read a copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM343794.pdf?source=govdelivery   Previous issues of Small Business Chronicles are available at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm299560.htm

Mar 12   FDA Declares Possibility of Potentially Fatal Irregular Heart Rhythm with Z-PAC Antibiotics Administration.  The FDA has issued a Drug Safety Communication warning the public that azithromycin (brand names: Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially sudden death irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. This communication is a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.  FDA released a statement on May 17, 2012, about a New England Journal of Medicine study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin, and levofloxacin, or no antibacterial drug.  The study reported an increase in cardiovascular deaths and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment (1 in 4000 for at risk patients).   

 

Pharmaceuticals in some form date back to the Middle Ages, but in modern days there are hundreds of prescription and over-the-counter medications available. Not only do humans consume pharmaceuticals, but livestock consumes millions of doses, as well. The global pharmaceutical market continues to grow year by year, and with it environmental concerns pertaining to not just production, but also consumer waste and disposal.

The US Department of Health and Human Services reports that at least half of all Americans take a minimum of one prescription drug, with one in six taking three or more. This doesn’t include the frequent use of over-the-counter medications for easing a headache, such as acetaminophen, aspirin, ibuprofen, naproxen sodium, or one of the many other maladies people suffer from on an occasional basis. Unused medication piles up in many households and waits for its final disposal. But where does it usually end up? Unfortunately, not always in the right place.

Pharmaceutical pollution is created by human activity. Residues come from manufacturing, veterinary use, agribusiness, hospitals, and community use. According to the US Geological Society, non-prescription drugs and steroids were more often detected in streams than prescriptions drugs, though a variety of prescription drugs were also present.

Improperly disposed medications, considered a toxic waste that finds its way into streams and drinking water, negatively impact humans, wildlife, and agriculture. At this time, many unknowns remain regarding the possible adverse effects on ecological receptors and humans from exposure to pharmaceutical pollutants in the environment. However, the possible risk to aquatic organisms due to exposure to these pollutants in the environment has been identified as a primary concern.

For medications intended for discard, pharmacists are expected to comply with a federal law, the Resource Conservation and Recovery Act (RCRA), as well as other regulations, for both hazardous and non-hazardous pharmaceuticals. However, many hospitals, unfortunately, continue to dispose of pharmaceuticals, except chemotherapy agents, by simply throwing them down the drain or sending them to the landfill.

According to the Minnesota Pollution Control Agency, the preferred method for destruction of household pharmaceuticals is incineration. If household garbage goes to an incinerator, medication gets disposed of safely. If household garbage goes to a landfill, it is not preferred over taking them to designated pick up sites, but is still preferable over flushing them down the toilet.

One topic that has not been discussed is pharmaceutical waste that comes from us, people. After taking medications each day, a large percentage of the active ingredients does not metabolize and ends up in human waste. Excess drugs in the bloodstream leave the body through urine and fecal matter, and the excreted chemicals flow with the sewage out of our homes to the streams and lakes. How can we help this form of pollution? Is it possible at this time?

Pharmaceutical Pollution Concern around the World

North America represents approximately 38% of the global pharmaceutical market with Europe following closely. Like in the US, the role of pharmaceuticals in water pollution is being taken as a major concern. The European Commission unveiled a new set of water rules, which for the first time included certain pharmaceutical products. Particular medications, such as pain relieving drug Diclofenac, are on the watch list.

According to Nature, an international weekly journal of science, “Many of Europe’s rivers are home to male fish that are ‘intersex’ and so display female sexual characteristics, including female reproductive anatomy. Some males also produce vitellogenin, a protein normally found in eggs that can be induced in males by hormone exposure. In one of the largest studies of the problem in 2004, the UK government’s Environment Agency found that 86% of male fish sampled at 51 sites around the country were intersex.” Toxicologists blame this feminization on endocrine-disrupting chemicals — particularly the active ingredient in the contraceptive pill, ethynyl oestradiol (EE2). This is a specific example of the pharmaceutical industries effect on the environment.

One very recent case of pharmaceutical pollution by a large company is a recent scandal in China. The Harbin Pharmaceutical Group, a major company in China’s HeiLongJiang province, decided to relocate after waste gases & water that exceeded legal pollution limits were released into the environment. They received a steep fine but other types of penalties have not yet been published.

Drug companies around the world are increasing production of both prescription and non-prescription pharmaceuticals for a growing market. As people continue to increase their intake of medication, so must they increase awareness of pharmaceutical pollution, and hold the health care industry accountable, as well.

Tackling the Problem

Pharmaceutical pollution can be stopped for the most part, but currently there are no commonly used methods of preventing it from human or animal waste. Instead, we must concentrate on ways of proper disposal and actually using them. We meaning consumers, hospital staff, pharmacy staff, scientists, and pharmaceutical companies.

In the United States, many environmental groups, health organizations, police, drugstores, and drug manufacturers participate in drug take-back programs. The only difficulty with these programs is that environmental groups and health organizations are sometimes inconvenient to reach, police may only take the drugs on certain days of the year, and some drugstores in certain states require payment for “envelopes” used for disposal. In addition, controlled substances may not be accepted by anyone other than the police since it is illegal to hand such medications over to someone else. Given this, some people who may normally recycle or properly dispose medication may resort to flushing them down the toilet or throwing them in the garbage for potential roving hands or animal thieves.

Unfortunately, people in many states in the US do not even know about the proper disposal of medications. The communication of proper medication disposal methods varies from state to state. Luckily some states have been successful in gathering unwanted medication. In Washington State alone, more than 75,000 pounds of drugs were returned to such places in 2 years alone.

How SHOULD pharmaceuticals ideally be disposed of? Currently high temperature incineration at suitably permitted facilities is the safest disposal method for toxic leftover medications. This is the method the pharmaceutical industry uses to dispose of their unwanted medicines. As the dangers of pharmaceutical pollution are becoming more and more apparent, awareness of regulatory institutions and pharmaceutical companies rises, as well. With more disposal centers, regulation, and education of the population, many of detrimental impact of pharmaceutical waste might be successfully negated in the near future.

For more information regarding this article please see link: http://www.kwikmed.org/environmental-impact-pharmaceutical-industry/


specialty pharma newsletter january 2013 prepared feb 11 2013 final.doc

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