Novo Nordisk Seeks FDA Ban on Compounded Semaglutide Formulations Amid Safety Concerns

Novo Nordisk's Request:
Novo Nordisk has asked the FDA to prohibit compounding pharmacies from producing alternative formulations of semaglutide, the key ingredient in its successful weight loss and diabetes treatments, Ozempic and Wegovy.

Safety Concerns:
Novo Nordisk argues that the complexity of semaglutide makes it unsafe for pharmacies to replicate, citing contaminants found in compounded formulations that could jeopardize patient safety.

Regulatory Context:
The FDA generally prohibits compounding of drugs that are mere replicas of existing medications, but allows it during periods of shortage. Novo Nordisk wants semaglutide to be included on the FDA's Demonstrable Difficulties Compounding List, which would restrict compounding regardless of availability.

Industry Response:
The Alliance for Pharmacy Compounding disputes Novo Nordisk's assertions, suggesting that the company's concerns are more about protecting profits than legitimate scientific concerns.

Eli Lilly's Actions:
Eli Lilly, the producer of rival drugs Zepbound and Mounjaro, has also taken steps to limit the availability of unapproved versions of their GLP-1 medications, including issuing cease-and-desist letters and pursuing false advertising lawsuits.

Legal Action:
The Outsourcing Facilities Association has initiated legal action against the FDA, contesting the decision to remove tirzepatide from the shortage list and seeking to have that decision overturned.