Is liraglutide FDA-approved?

Yes, as specific products: Victoza, Saxenda and Xultophy 100/3.6 injections and generic liraglutide injections are FDA-approved for the uses in their labels, and they're prescription only.

Checked 23 Oct 2026. The sources are below.

Liraglutide

Also: NN2211, NNC 90-1170

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.

  • Victoza (liraglutide) injection

    Subcutaneous

    Type 2 diabetes mellitus: glycemic control with diet and exercise in adults and children aged 10 and older, and reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease.

    Source: DailyMed label, checked 23 Oct 2026

  • Saxenda (liraglutide) injection

    Subcutaneous

    With a reduced calorie diet and increased physical activity: "to reduce excess body weight and maintain weight reduction long term" in the adults and children aged 12 and older that the label defines.

    Source: DailyMed label, checked 23 Oct 2026

  • Xultophy 100/3.6 (insulin degludec and liraglutide) injection

    Subcutaneous

    Type 2 diabetes mellitus: glycemic control with diet and exercise in adults.

    Source: DailyMed label, checked 23 Oct 2026

  • Generic liraglutide injection, from several manufacturers, with Victoza as the reference product

    Subcutaneous

    As stated on each product's label, which may not list every use on Victoza's (approved through abbreviated new drug applications, ANDAs).

    Source: Drugs@FDA, checked 23 Oct 2026

  • Generic liraglutide injection, from several manufacturers, with Saxenda as the reference product

    Subcutaneous

    As stated on each product's label (approved through ANDAs).

    Source: Drugs@FDA, checked 23 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each product above as "Prescription".

    Source: Drugs@FDA, checked 23 Oct 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 23 Oct 2026

How to track it in Peptimes

Add liraglutide 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 Victoza, Saxenda and generic entries above give the detail. Xultophy 100/3.6 has no Library entry.

  • 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 liraglutide or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 022341 (Victoza), NDA 206321 (Saxenda) and BLA 208583 (Xultophy 100/3.6), checked 23 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Liraglutide, checked 23 Oct 2026: the code names NN2211 and NNC 90-1170.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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