Drugs

FDA Approves Teva’s Generic Seizure Drug

FDA has approved a Teva Pharmaceuticals ANDA for the first generic version of Lundbeck’s Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments. Teva had trouble obtaining drug samples from Lundbeck to conduct bioequivalence testing, according to the agency. It intervened last year, and began publishing a list of inquiries from generic drug developers seeking FDA’s help in obtaining samples from brand companies. FDA noted that the brand companies were blocking access to the samples because the brand products are subject to limited distribution programs.

Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss, and Teva’s generic is now part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin to ensure safe use of the product. “Brand and generic drug makers are required to develop a single shared-system REMS program (unless FDA waives the single shared system requirement) when a generic drug seeks approval and the brand drug has a REMS associated with it,” FDA says.

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