Is letrozole FDA-approved?

Yes, as specific products: Femara tablets and generic letrozole tablets are FDA-approved for the uses in their labels, and they're prescription only.

Checked 1 Nov 2026. The sources are below.

Letrozole

Also: Femara, CGS-20267

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
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.

  • Femara (letrozole) tablets

    Oral

    The uses in its label.

    Source: DailyMed label, checked 1 Nov 2026

  • Generic letrozole tablets, from several manufacturers

    Oral

    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

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    A placebo-controlled trial in 5,187 postmenopausal women who had completed earlier tamoxifen treatment for early breast cancer: at a median 2.4 years, there were fewer recurrences or new cancers in the other breast with letrozole (75) than with placebo (132). Deaths didn't differ significantly.

    Source: PMID 14551341, checked 1 Nov 2026

How to track it in Peptimes

Add letrozole 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. It’s logged as oral, so there’s no injection site to record.
  • 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 letrozole or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 020726 (Femara), checked 1 Nov 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Letrozole, checked 1 Nov 2026: the code name CGS-20267.

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

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