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# Restrictions Asked for Ozempic ANDAs
- URL: https://www.fdaweb.com/restrictions-asked-for-ozempic-andas/
- Published: 2025-08-14T12:00:00.000Z
- Updated: 2026-09-14T15:19:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159689

An 8/12 petition submitted by Foley & Lardner on behalf of a client asks FDA to not approve any ANDA submission for a generic version of Nova Nordisk’s Ozempic (semaglutide injection) unless specified conditions are met. The [petition](https://www.regulations.gov/document/FDA-2025-P-3103-0001?ref=fdaweb.com) says FDA should ensure that:

- the generic drug-device product includes a pen injector that is functionally equivalent in specified ways to Ozempic; and
- if the semaglutide active pharmaceutical ingredient (API) is produced via intermediates, such as P29, derived through a fermentation route, the API should be classified as a hybrid API, not a purely synthetic one with established adequate controls to reduce immunogenicity risk.

“Approving semaglutide ANDAs that rely on Ozempic as the reference-listed drug with non-equivalent devices and hybrid API jeopardizes patient safety and undermines the foundation of generic drug approval,” the petition says. “The effectiveness and safety of Ozempic depend significantly on the functional design and ease of use of its auto-injector. While equivalence is essential for the active substance, it alone cannot assure therapeutic equivalence for a drug-device combination. Functional differences in generic auto-injectors may introduce risks of dosing errors, reduced adherence, and compromised treatment outcomes.”