Drugs

Add Semaglutide to DDC Lists: Novo Nordisk

Novo Nordisk is petitioning FDA to add its semaglutide products (Ozempic and Wegovy) to the Demonstrable Difficulties for Compounding (DDC) lists. The firm’s nominating petition says the products belong on the lists “due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physiochemical and analytical testing.”

FDA permitted compounding of semaglutide products earlier this year when they were in shortage. The petition asks the agency to convene an advisory committee to consider whether semaglutide should be added to the DDC lists.

It gives these factors as reasons for its request:

the complexity of semaglutide products’ formulation;
the complexity of semaglutide products’ delivery mechanisms;
semaglutide products dosage forms are complex;
semaglutide products’ complexity in achieving and assessing bioavailability;
the complexity of semaglutide products’ compounding process; and
compounding semaglutide requires complex physiochemical or analytical testing.

“The risks with compounding semaglutide products are numerous and outweigh any actual or potential benefit of compounded semaglutide products,” Novo Nordisk says.

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