Drugs

Lawsuit Against FDA Dismissed on Ripeness Grounds

The Washington, DC District Court 9/10 dismissed as not ripe for review a Vanda Pharmaceuticals lawsuit against FDA that challenged the agency’s bioequivalence determination of a generic competitor to sleep drug Hetlioz, calling it arbitrary and capricious, in violation of the Administrative Procedure Act (APA). Vanda argued that although FDA had consistently told ANDA applicants that appropriately designed bioequivalence studies must include subjects reflecting the demographic of the intended population, MSN Pharmaceuticals only tested its generic form of Hetlioz in 44 Indian males.

The court ruled that Vanda’s APA challenges are unripe for judicial review because FDA is currently evaluating the same scientific questions in its pending review of a Vanda citizen petition, which it intends to decide by early next year. “The court will, accordingly, dismiss the APA claims without prejudice to renewal should any dispute remain after the FDA’s now imminent decision,” the court ruled.

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