U.S. Food and Drug Administration (FDA)
Is Exenatide legal in United States?
Generics availableByetta and Bydureon BCISE are listed as discontinued; an FDA-approved generic exenatide (Amneal) is on the market
Approved generic versions are sold.
Exenatide, the first GLP-1 medicine, was FDA-approved as Byetta in April 2005 (and later as extended-release Bydureon and Bydureon BCISE) for type 2 diabetes. FDA's Drugs@FDA data now lists Byetta and the Bydureon products as discontinued, while a generic synthetic exenatide from Amneal (approved 19 November 2024) is listed as marketed. Exenatide is not approved for weight loss. No compounding-specific FDA statement was found for exenatide; the general 503A and 503B rules on essentially-copy products apply.
Last verified 2026-09-29 · how we verify
Exenatide elsewhere
Sources (3)
- 01BYETTA (exenatide) injection prescribing informationU.S. Food and Drug Administration · 2025-06 · accessed 2026-09-29
- 02BYDUREON BCISE (exenatide extended-release) prescribing informationU.S. Food and Drug Administration · 2025-06 · accessed 2026-09-29
- 03Drugs@FDA data via openFDA: exenatide applications (Byetta, Bydureon, generic)U.S. Food and Drug Administration · 2026-09-24 · accessed 2026-09-29