Drugs

Novo Nordisk Supplements Semaglutide Petition

Novo Nordisk has submitted to FDA its second supplement to its nomination of semaglutide products (Ozempic and Wegovy) to the list of drug products that present demonstrable difficulties for compounding under the Federal Food, Drug, and Cosmetic Act (FFDCA). “This supplement adds to the body of evidence that demonstrates the difficulties in attempting to compound drug products with semaglutide, which are reasonably likely to lead to an adverse effect on the safety or effectiveness of semaglutide drugs, taking into account the risks and benefits to patients,” the supplement says.

The document “analyzes bulk drug substances and compounded drugs claiming to contain semaglutide that continue to be marketed following the removal of semaglutide injection products from FDA’s drug shortage list and the end of FDA’s enforcement discretion period for drugs compounded under sections 503A and 503B of the FFDCA,” it says. Novo Nordisk says it is providing data and analyses that highlight the complexities associated with semaglutide products’ formulation, delivery mechanism, dosage form, achievement of bioavailability, compounding process, and physicochemical and analytical testing.

‘We urge the agency again to take action against unsafe and unapproved compounded semaglutide products as requested in the citizen petition,” the supplement concludes. “The evidence in the citizen petition and each supplement has demonstrated that semaglutide products are too difficult to compound. FDA should take action using its existing authorities under federal law to stop the dissemination of unsafe, compounded semaglutide products.”

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