FDA withdraws approval of Byetta and Bydureon at applicants' request
Byetta and Bydureon lose FDA approval September 3, 2025, though pharmacies may still have inventory to dispense; the notice sets out no transition plan for patients.
The Food and Drug Administration is withdrawing its approval of Byetta, Bydureon, Bydureon Pen and Bydureon BCise, along with 35 other brand-name drug applications, at the request of the companies that held them. The action was published in the Federal Register on August 4, 2025, under Docket No. FDA-2025-N-2422 and cited as 90 FR 36440 [1].
The notice covers 39 new drug applications (NDAs) from multiple applicants [1]. Besides the four Byetta and Bydureon products, the list includes Hexadrol (dexamethasone) elixir, tablets and injection; Sinequan (doxepin) capsules and concentrate; Loxitane and Loxitane C (loxapine); Surmontil (trimipramine); Vivactil (protriptyline); Drytec Technetium Tc99m Generator; Thallous Chloride Tl-201 injection; and M.V.I. Pediatric [1].
Under FDA rules at 21 CFR 314.150(c), a company can ask the agency to withdraw approval of an application when a product is no longer being marketed [1]. In this case, the applicants notified the agency in writing that the drug products were no longer marketed and requested the withdrawals, and by making that request they waived their opportunity for a hearing, according to the notice [1]. The notice states that a withdrawal under this section is "without prejudice to refiling," meaning an applicant could seek approval for the same product again later [1].
The withdrawal takes effect September 3, 2025 [1]. The notice says product already in inventory may be dispensed until it is depleted or expires [1]. It does not say how much Byetta or Bydureon remains in pharmacies or wholesalers, and it does not describe a recall [1].
The notice does not give a reason beyond the applicants' statements that the products are no longer marketed [1]. It does not name a replacement product, describe a transition plan for people currently using these medicines, or list alternative treatments [1]. A correction to the notice was published in the Federal Register on October 3, 2025 [1].
Why it matters for patients
Byetta and Bydureon will no longer hold FDA approval as of September 3, 2025 [1]. Existing inventory can still be dispensed until it runs out or expires [1]. That means some people may be able to keep filling prescriptions for a period and others may find supply has already ended, depending on what their pharmacy has on hand. The amount of remaining supply has not been disclosed [1].
The notice applies only to the applications named in it [1]. It does not change the approval status of any other product, and it does not include instructions for patients or prescribers on what to do about a current prescription [1].
Because the withdrawal is without prejudice to refiling, a future approval request is possible, but no refiling has been announced [1].
What happens next
September 3, 2025: the withdrawal of approval takes effect [1].
October 3, 2025: FDA published a correction to the August notice [1].
Not yet known: how long remaining inventory will last, whether the applicants will refile, and how many people in the United States are still using Byetta or Bydureon. The notice does not say [1].
Sources
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