Comment from Novo Nordisk, Inc.

Summary: Novo Nordisk, Inc. opposes the nomination of semaglutide to the 503B Bulks List, arguing that there is no established clinical need for compounded versions of the drug. The company contends that FDA-approved semaglutide medicines are safe and effective for various patients and that compounded products pose significant quality and safety risks, including potential immunogenicity from impurities.