FDA withdrawal of Byetta and Bydureon approvals takes effect
Byetta and Bydureon no longer have FDA approval as of September 3, 2025, after their makers said the exenatide products were no longer being marketed.
Approvals for Byetta and Bydureon, two older GLP-1 medicines made with the drug exenatide, formally ended on September 3, 2025. That is the date the FDA's withdrawal of 39 new drug applications took effect [1].
The action was announced in a Federal Register notice published August 4, 2025, under Docket No. FDA-2025-N-2422 and cited as 90 FR 36440 [1]. The notice states that the companies holding the applications told the FDA in writing that the products were no longer marketed and asked the agency to withdraw approval. The applicants also waived their opportunity for a hearing [1].
The withdrawal covers the applications for Byetta and for Bydureon and Bydureon BCise, along with 36 other new drug applications from multiple applicants [1]. The notice says the withdrawals were made under the process in 21 CFR 314.150(c), which is without prejudice to refiling, meaning a company could seek approval of one of these products again [1].
Once approval is withdrawn, the product no longer has an approved application. Introducing it into interstate commerce without an approved application would violate the Federal Food, Drug and Cosmetic Act [1].
The notice does not say how much Byetta or Bydureon supply remains in pharmacies or wholesalers, when the last shipments were made, or whether another manufacturer intends to take over either product. Those details have not been disclosed [1]. It also does not say the medicines were pulled for safety or effectiveness reasons; the stated reason was that they were no longer being marketed [1].
Why it matters for patients
Exenatide is one of the earlier GLP-1 drugs, and Byetta and Bydureon are the brand-name versions affected here [1]. People who currently have a prescription for either product face practical questions the notice does not answer: whether their pharmacy can still fill it, how long remaining stock lasts, and what their prescriber would consider instead. The notice does not address any of that, and no transition guidance for patients appears in it [1].
Separately, the notice does not discuss whether any generic or other versions of exenatide remain approved, and it does not list how many patients were using these products [1]. That information has not been reported.
The 39 withdrawn applications also include products in other treatment areas, such as the antipsychotic Loxitane and the antidepressant Sinequan, which were listed alongside the exenatide products [1].
What happens next
September 3, 2025 was the effective date of the withdrawal, and no further dated milestones appear in the notice [1]. Because the withdrawals were made without prejudice to refiling, any company could file again for approval of one of these products at any time; no such refiling has been announced [1].
For anyone with questions about an existing prescription for Byetta or Bydureon, the notice directs general inquiries about the action to the FDA's Center for Drug Evaluation and Research [1]. It does not provide patient-specific instructions.
Sources
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