FDA withdraws the Byetta and Bydureon approvals

The Food and Drug Administration has formally withdrawn approval of 39 new drug applications, including the exenatide products Byetta, Bydureon, Bydureon Pen and Bydureon BCise. The action was published in the Federal Register on August 4, 2025, and the withdrawals took effect September 3, 2025 ^[1].

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" ^[1]. In other words, the companies asked the agency to close out the approvals for drugs they had already stopped selling. The notice adds that the applicants "have also, by their requests, waived their opportunity for a hearing" ^[1].

The paperwork route matters. FDA used the process in 21 CFR 314.150(c), which covers voluntary withdrawals at an applicant's request ^[1]. The notice states that a withdrawal under that section "is without prejudice to refiling," meaning a company could, in principle, submit a new application for the same product later ^[1]. Under the terms of the withdrawal, product already sitting in distribution channels or pharmacy inventory can still be dispensed until it is used up or reaches its expiration date ^[1].

The list of 39 applications spans many older brands from several companies, not just diabetes drugs. It includes Hexadrol (dexamethasone) tablets, elixir and injection from Aspen Global; the antidepressants Vivactil (protriptyline), Surmontil (trimipramine) and Sinequan (doxepin); Loxitane (loxapine); and imaging agents such as the Drytec Technetium Tc99m generator and Thallous Chloride Tl-201 from GE HealthCare ^[1]. The docket number is FDA-2025-N-2422, and the notice appears at 90 FR 36440 ^[1].

Why it matters for patients

Byetta and the Bydureon line were exenatide products in the same broad GLP-1 class that now includes semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound). For anyone still holding a prescription for one of these exenatide products, the practical effect is that the brand is no longer an approved, marketed option in the United States going forward. Remaining stock can be dispensed until it runs out or expires, but no new supply is being produced under these approvals ^[1].

The withdrawal is administrative housekeeping that follows a commercial decision, not a finding that the drugs were unsafe or ineffective. The notice contains no safety language at all; it says only that the products are no longer marketed and that the applicants asked for the approvals to be pulled ^[1].

There is a second, quieter consequence. When a brand's approval is withdrawn, it can affect whether generic copies that referenced that brand remain available, because generics rely on the brand's approved listing. The Federal Register notice does not address generic exenatide or list any effect on abbreviated applications, so what happens to generic versions is not addressed in this document ^[1].

The notice also does not explain why the companies stopped marketing exenatide, does not say how much inventory remains, and does not offer guidance on alternatives ^[1]. Those questions are not answered in the source material. Anyone affected would need to take that up with their own prescriber or pharmacy.

What happens next

The key dates are already behind us. The document went on public inspection August 1, 2025, published August 4, 2025, and approval was withdrawn as of September 3, 2025 ^[1]. Public comments are no longer being accepted ^[1].

FDA later issued a correction to the same docket. A follow-up document, published October 3, 2025, is labeled "Notice; correction" and carries the same title, "Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction" ^[1]. The content of that correction is not included in the source text here, so it is not yet known from these documents whether it changed any of the listed products or dates.

Because the withdrawal was voluntary and is "without prejudice to refiling," the door is technically open for a future application, though nothing in the notice suggests one is planned ^[1].