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# Novo Nordisk Supplements Semaglutide Petition
- URL: https://www.fdaweb.com/novo-nordisk-supplements-semaglutide-petition/
- Published: 2026-01-20T12:00:00.000Z
- Updated: 2026-09-14T15:31:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160515

Novo Nordisk has submitted to FDA its second supplement to its nomination of semaglutide products (Ozempic and Wegovy) to the list of drug products that present demonstrable difficulties for compounding under the Federal Food, Drug, and Cosmetic Act (FFDCA). “This [supplement](ttps://downloads.regulations.gov/FDA-2024-P-5378-0012/attachment%5F1.pdf) adds to the body of evidence that demonstrates the difficulties in attempting to compound drug products with semaglutide, which are reasonably likely to lead to an adverse effect on the safety or effectiveness of semaglutide drugs, taking into account the risks and benefits to patients,” the supplement says.

The document “analyzes bulk drug substances and compounded drugs claiming to contain semaglutide that continue to be marketed following the removal of semaglutide injection products from FDA’s drug shortage list and the end of FDA’s enforcement discretion period for drugs compounded under sections 503A and 503B of the FFDCA,” it says. Novo Nordisk says it is providing data and analyses that highlight the complexities associated with semaglutide products’ formulation, delivery mechanism, dosage form, achievement of bioavailability, compounding process, and physicochemical and analytical testing.

‘We urge the agency again to take action against unsafe and unapproved compounded semaglutide products as requested in the citizen petition,” the supplement concludes. “The evidence in the citizen petition and each supplement has demonstrated that semaglutide products are too difficult to compound. FDA should take action using its existing authorities under federal law to stop the dissemination of unsafe, compounded semaglutide products.”