Drugs

Court Orders Advance FDA Notice on Crestor ANDA Decisions

As FDA prepares to make approval decisions on a slew of ANDAs for generic copies of AstraZeneca’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium), the DC federal court has ordered that it be provided 24 hours notice before any decision is rendered on any ANDA or a related citizen petition that seeks a block on the approvals if they include labeling carve-outs that the company has argued against (see earlier story). The court says that it will call a hearing where all parties will be required to appear on two-hours notice so that FDA can present its decisions.

The court order was considered a compromise so AstraZeneca can obtain “meaningful judicial consideration of its motion” for a temporary restraining order before any ANDAs are approved. AstraZeneca sought advance notice on FDA’s decision because “there is every reason to believe” that the generic manufacturers will “flood the market immediately with at least six months’ worth of generic product,” causing “AstraZeneca’s market share [to] drop precipitously,” and the court agreed.

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