Drugs

Texas Court Gives FDA Win in Compounding Enforcement

A Northern Texas federal judge has denied a preliminary injunction sought by industry trade group Outsourcing Facilities Association to delay FDA enforcement actions against compounding pharmacies that make copies of Novo Nordisk’s weight-loss drug Wegovy (semaglutide) and the diabetes medication Ozempic (semaglutide).

FDA earlier allowed compounding pharmacies to sell copies of the drugs when the medications were in short supply. In February, the agency rescinded this exception after declaring the shortage over, and set deadlines for enforcement action against pharmacies that compounded Novo Nordisk’s drug.

“We are pleased the court has rejected the compounders’ attempts to undermine FDA’s data-based decision that the shortage of Wegovy and Ozempic is resolved,” the company said in reaction to the court’s decision, which was sealed and not publicly available at press time.

Outsourcing Facilities Association said its organization is “deeply disappointed” the court failed to consider "clear and convincing evidence" that existing supply of semaglutide doesn't meet consumers' demand. “We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA,” it said. "We will not stop in our efforts to ensure that patients can get access to this vital medication.”

In 12/2024, FDA issued a similar declaration that Eli Lilly’s weight loss and diabetes medication tirzepatide, sold under the brand names Mounjaro and Zepbound, was no longer in short supply. The Outsourcing Facilities Association subsequently failed in its bid to gain a preliminary injunction to continue marketing compounded tirzepatide.

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