Is cetrorelix FDA-approved?

Yes, as specific products: Cetrotide and generic cetrorelix acetate for injection are FDA-approved, by prescription, for the use in their labels.

Checked 1 Nov 2026. The sources are below.

Cetrorelix

Also: Cetrotide, cetrorelix acetate, SB-75

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Subcutaneous
Updated
1 Nov 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.

  • Cetrotide (cetrorelix acetate for injection)

    Subcutaneous

    Inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

    Source: DailyMed label, checked 1 Nov 2026

  • Generic cetrorelix acetate for injection, from several manufacturers, with Cetrotide as the reference product

    Subcutaneous

    As stated on each product's label (approved through abbreviated new drug applications, ANDAs).

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add cetrorelix 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 entries above give the products it applies to.

  • 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 cetrorelix or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 021197 (Cetrotide), checked 1 Nov 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Cetrorelix, checked 1 Nov 2026: its formula, C70H92ClN17O14.

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

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