Comment from Covington & Burling LLP on Behalf of Novo Nordisk Inc.

Summary: Novo Nordisk Inc. opposes the nomination of semaglutide to the 503B Bulks List, arguing that there is no demonstrated clinical need for compounding since FDA-approved versions already exist. The company contends that compounded semaglutide poses significant safety risks, including sterility and potency issues, and that its inclusion would undermine the drug approval process.