Comment from Covington & Burling LLP

Summary: Novo Nordisk Inc. opposes the nomination of liraglutide to the 503B Bulks List, arguing that there is no clinical need for compounding since FDA-approved versions of the drug already exist. The company contends that compounding poses significant safety risks, including immunogenicity and subpotency, and would undermine incentives for manufacturers to develop high-quality, approved medicines.