Drugs

Put Semaglutide Drugs on DDC Lists: Novo Nordisk

Novo Nordisk is supporting its 10/22 nomination of semaglutide drugs to the lists of drug products that present demonstrable difficulties for compounding (DDC) lists with an 11/13 petition calling on FDA to take three specific actions to promulgate regulations to place the products on the lists. The petition says Novo Nordisk’s nomination “explained that semaglutide products belong on these lists due to the complexities associated with their formulations, delivery mechanisms, dosage forms, bioavailability achievement, compounding processes, and physicochemical and analytical testing.”

The petition says the company submitted the nomination to help ensure patients are not further harmed by the use of potentially dangerous, unapproved compounded drugs.

Novo specifically asks FDA to:

issue a direct final rule to add semaglutide products to the Section 503A DDC list before consultation with an advisory committee to protect the public health;
convene and consult an advisory committee to discuss the addition of semaglutide products to the DDC lists; and
after consultation with the advisory committee, propose and finalize rules to add semaglutide products to the DDC lists.

Novo Nordisk’s semaglutide products are Rybelsus, Ozempic, and Wegovy. It says its nomination included “substantial evidence” of differences between the three approved drugs and compounded products purporting to contain semaglutide, and the significant risks to public safety and health associated with 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