Drugs

FDA Rejects 2 Dr. Reddy’s Generic Drug Applications

FDA has issued Dr. Reddy’s Laboratories two complete response letters for generic copies of Teva’s multiple sclerosis drug Copaxone (glatiramer acetate injection) and Merck’s female contraceptive Nuvaring (etonogestrel/ethinyl estradiol) vaginal ring. Dr. Reddy’s declined to disclose the reasons for the FDA rejection letter, but said it will prepare responses to address the issues.

Dr. Reddy’s has received a number of Form FDA-483s recently due to inspection findings at several manufacturing facilities in India. For example, one was issued 7/12 after an inspection at Dr. Reddy’s Laboratories Unit 2 active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India. The inspection observations were:

investigations into product complaints and out-of-specification quality control analytical results, related to finished API product quality failures, are not adequate;
preventive controls over electronic inventory and warehousing management systems are not effectively established to prevent product mix-ups and ensure traceability for the life cycle of the material;
materials are not stored under appropriate conditions and according to the manufacturer’s specifications that guarantee no adverse effect on the material’s quality, purity, and potency and are not appropriately reevaluated to determine their suitability for use after prolonged storage in and exposure to heat and humidity.

FDA also recently released an FDA-483 following a 6/13-6/21 inspection at another Dr. Reddy’s drug manufacturing facility in Andhra Pradesh, India. Inspection observations included failing to establish acceptance activities prior to performance of validation activities; and failing to correctly translate device design into production specifications.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome