Is teduglutide FDA-approved?

Yes, as a specific product: Gattex (teduglutide) for injection is FDA-approved, by prescription, for the uses in its label.

Checked 25 Oct 2026. The sources are below.

Teduglutide

Also: Gattex, Revestive, ALX-0600

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

US regulatory status

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

  • Gattex (teduglutide) for injection

    Subcutaneous

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Prescription

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

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add teduglutide 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.

  • 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 peptide tracker app page.

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

More sources

  • FDA, Drugs@FDA, NDA 203441 (Gattex), checked 25 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Teduglutide, checked 25 Oct 2026: the names Revestive and ALX-0600.

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

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