April 30 (Reuters) – The U.S. Food and Drug Administration on Thursday proposed excluding Novo Nordisk and Eli Lilly’s weight-loss drugs from its list of active ingredients that outsourcing facilities may use to make compounded medicines.
If finalized, the move would restrict outsourcing facilities from compounding except in cases of drug shortages, bolstering Novo and Lilly’s efforts to rein in unauthorized versions that have been eating into sales of their blockbuster treatments.
U.S.-listed shares of Novo rose nearly 6%, while Lilly gained more than 8% in morning trading.
The FDA had earlier signaled a crackdown on compounded weight-loss drugs, including moves to restrict ingredients used in unapproved products marketed by compounding pharmacies as alternatives to authorized treatments.
Compounding, in which pharmacies mix ingredients for specialized medicines or to copy a drug but at different dosages, has flourished as Americans chase more affordable options.
The regulator said on Thursday it did not identify a clinical need for outsourcing facilities to compound semaglutide, the active ingredient of Novo’s Wegovy and Ozempic, and tirzepatide, sold as Zepbound and Mounjaro by Lilly, from bulk drug substances. The proposal also includes Novo’s older molecule liraglutide.
The FDA was reviewing nominations for the so-called 503B bulks list, which identifies drug ingredients that outsourcing facilities may use in compounding.
The agency maintains a separate list, called 503A bulks list, for active ingredients that can be compounded by state-licensed physicians and pharmacists.
Compounding is legal under the Federal Food, Drug and Cosmetic Act in certain circumstances such as when prescribed by a physician to address patient side-effects or during a drug shortage.
(Reporting by Mrinalika Roy and Mariam Sunny in Bengaluru; Editing by Leroy Leo and Shilpi Majumdar)
