Is follitropin FDA-approved?

Yes, as specific products: Gonal-f, Gonal-f RFF, Gonal-f RFF Redi-ject and Follistim AQ Cartridge are FDA-approved, by prescription, for the uses in their labels.

Checked 1 Nov 2026. The sources are below.

Follitropin

Also: FSH, follicle-stimulating hormone, follitropin alfa, follitropin beta, Gonal-f, Follistim AQ, Puregon, Ovaleap, Bemfola

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.

  • Gonal-f (follitropin alfa) for injection, multi-dose

    Subcutaneous

    In the women the label defines, inducing ovulation and pregnancy, and developing multiple follicles as part of assisted reproductive technology (ART); in men with the hypogonadotropic hypogonadism the label defines, inducing sperm production.

    Source: DailyMed label, checked 1 Nov 2026

  • Gonal-f RFF (follitropin alfa) for injection

    Subcutaneous

    As stated on its label.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Gonal-f RFF Redi-ject (follitropin alfa) injection pen

    Subcutaneous

    In the women the label defines: inducing ovulation and pregnancy, and developing multiple follicles as part of an ART cycle.

    Source: DailyMed label, checked 1 Nov 2026

  • Follistim AQ Cartridge (follitropin beta) injection

    Subcutaneous

    In the women the label defines, inducing ovulation and pregnancy, and pregnancy in controlled ovarian stimulation for IVF or ICSI; in men with the hypogonadotropic hypogonadism the label defines, inducing sperm production.

    Source: DailyMed label, 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 follitropin 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 peptide tracker app page.

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

More sources

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

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