Drugs

Appeals Court OKs Otsuka Abilify Suit Dismissal

The Court of Appeals for the District of Columbia has upheld a district court decision that FDA acted appropriately in approving Alkermes’ Aristada during a period of exclusivity for Otsuka’s Abilify Maintena. Otsuka had opposed the Alkermes application, saying approval would violate an ongoing period of marketing exclusivity for Abilify Maintena. Otsuka argued that both drugs ultimately metabolize in the body into the same molecule and that the Alkermes application relied in part on studies showing the safety and efficacy of an Abilify Maintena precursor.

FDA rejected Otsuka’s arguments, the appeals court decision says, relying on the fact that the two products have different active moieties. Otsuka sought judicial review of that decision arguing, among other things, that the agency’s same-moiety limitation on the scope of a drug’s marketing exclusivity conflicts with the Federal Food, Drug and Cosmetic Act. The appeals court said it agreed with the district court’s conclusion that the agency’s same-moiety test was a reasonable construction of the law and was consistent with agency regulations.

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