Drugs

Compounders Sue FDA Over Semaglutide Shortages

Drug compounding operations have filed suit against FDA in northern Texas federal court, seeking an order to reverse the agency decision last week to remove semaglutide (Novo Nordisk’s Wegovy and Ozempic) from the drug shortage list (see earlier story). “Arbitrarily dismissing evidence that the shortage persists, FDA removed semaglutide from the shortage list without notice-and-comment rulemaking, in contravention of its statutory directive, and without evidentiary support,” the Outsourcing Facilities Association’s complaint says. “Indeed, the agency confirmed that there remains a semaglutide shortage and that many patients cannot access semaglutide products.” It also argues that Novo Nordisk recently declared in an SEC filing that “supply constraints” and “drug shortage notifications” will continue into the foreseeable future.

The suit is also seeking an order to permanently and temporarily enjoin FDA from taking action against plaintiffs or their members for engaging in compounding of semaglutide.

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