Byetta and Bydureon approvals formally cease to exist

The Food and Drug Administration's withdrawal of approval for the exenatide applications NDA 021773, NDA 022200 and NDA 209210 — the applications behind Byetta, Bydureon and Bydureon BCise — took effect on September 3, 2025. The action was part of a larger FDA notice withdrawing approval of 39 new drug applications from multiple companies ^[1].

The notice was published in the Federal Register on August 4, 2025, under Docket No. FDA-2025-N-2422, at 90 FR 36440 ^[1]. Its "DATES" line is short and specific: "Approval is withdrawn as of September 3, 2025" ^[1].

What the FDA notice actually says

This was not a safety action. According to the notice, the applicants "informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications" under the process in 21 CFR 314.150(c) ^[1]. By making those requests, the companies also waived their opportunity for a hearing ^[1].

The notice adds one detail that matters for the long term: withdrawal under § 314.150(c) "is without prejudice to refiling" ^[1]. In plain terms, the door is not permanently shut — a company could file again in the future, though nothing in the notice says anyone plans to.

The practical legal effect is that, as of September 3, 2025, there is no longer an approved application covering these products. Shipping them in interstate commerce without an approved application violates the Federal Food, Drug, and Cosmetic Act.

The FDA notice covers a long and varied list of 39 applications, including older products such as Hexadrol (dexamethasone), Sinequan (doxepin HCl), Loxitane (loxapine succinate) and diagnostic agents like Thallous Chloride Tl-201 ^[1]. The version of the table available for this article is truncated and does not display every line item, so the entries beyond those listed above could not be read directly from the published text. The notice gives no drug-by-drug explanation beyond the statement that the products are no longer marketed ^[1].

The agency later issued a correction to the same docket. Federal Register records show a "Notice; correction" published on October 3, 2025, under document number 2025-19440 ^[1]. The content of that correction is not described in the material available here, so what it changed is not yet known.

Why it matters for patients

For people using GLP-1 medicines today, the immediate effect is mostly symbolic. Exenatide products were already off the market before the paperwork was finalized — that is the stated reason the applications were withdrawn in the first place ^[1]. An FDA withdrawal of this type follows a company's decision to stop selling, rather than causing it.

Still, the formal end of these approvals has some consequences worth understanding. Once an application is withdrawn, the reference listed drug that generic makers would rely on is gone, which affects whether copies can be approved through the usual generic pathway. It also means any product marketed under these names now lacks an approved application behind it.

The notice says nothing about semaglutide (Ozempic, Wegovy, Rybelsus) or tirzepatide (Mounjaro, Zepbound), and nothing in the sources links this action to supply, pricing or coverage of those newer drugs ^[1]. Anyone with questions about switching away from a discontinued medicine is in a conversation for their own clinician, not one this notice answers.

What happens next

Key dates from the record: the notice published August 4, 2025 ^[1]; the withdrawals took effect September 3, 2025 ^[1]; and a correction notice appeared in the same docket on October 3, 2025 ^[1]. Public comments on the docket are closed ^[1]. Whether any applicant will use the "without prejudice to refiling" option is not addressed in the notice ^[1].