Is exenatide FDA-approved?

Yes, as specific products: Byetta, Bydureon, Bydureon BCise and a generic exenatide injection are FDA-approved, but Drugs@FDA lists most of them as discontinued.

Checked 25 Oct 2026. The sources are below.

Exenatide

Also: Byetta, Bydureon, Bydureon BCise, exendin-4, AC2993, LY2148568

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Subcutaneous
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Byetta (exenatide) injection

    Subcutaneous

    Adults with type 2 diabetes mellitus: glycemic control with diet and exercise. Drugs@FDA lists Byetta's current application (NDA 021773) as discontinued; an older listing (NDA 021919, Amylin) still shows "Prescription".

    Source: DailyMed label, checked 25 Oct 2026

  • Bydureon (exenatide extended-release) injectable suspension, vial and pen

    Subcutaneous

    Type 2 diabetes mellitus: glycemic control with diet and exercise in adults and children aged 10 and older. Drugs@FDA lists both forms as discontinued.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Bydureon BCise (exenatide extended-release) injectable suspension

    Subcutaneous

    Type 2 diabetes mellitus: glycemic control with diet and exercise in adults and children aged 10 and older. Drugs@FDA lists it as discontinued.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Generic exenatide injection, with Byetta as the reference product

    Subcutaneous

    As stated on its label, which matches Byetta's use (approved through an abbreviated new drug application, ANDA). Drugs@FDA lists it as discontinued.

    Source: DailyMed label, checked 25 Oct 2026

  • Prescription

    Prescription only. Each product's label is marked "Rx only".

    Source: DailyMed label, checked 25 Oct 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

Drugs@FDA now lists every US exenatide product above as discontinued. FDA approved them, but none is marketed in the US today.

How to track it in Peptimes

Add exenatide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.

  • Logging: the amount you took and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the GLP-1 tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell exenatide or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 021773 (Byetta), NDA 022200 (Bydureon and Bydureon Pen), NDA 209210 (Bydureon BCise) and ANDA 206697 (generic exenatide), checked 25 Oct 2026: product, route and marketing status (each “Discontinued”).
  • FDA, Global Substance Registration System, Exenatide, checked 25 Oct 2026: the names exendin-4, AC2993 and LY2148568.

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