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# FDA Will Review Myfembree sNDA with New Safety Info
- URL: https://www.fdaweb.com/fda-will-review-myfembree-snda-with-new-safety-info/
- Published: 2022-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:47:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151960

FDA has accepted for review an sNDA submitted by Pfizer and Myovant Sciences for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). A Pfizer [statement](https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-announce-fda-acceptance-1?ref=fdaweb.com) says the sNDA proposes updates to the Myfembree labeling based on safety and efficacy data from the Phase 3 LIBERTY withdrawal study in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years. FDA set 1/29/23 as the PDUFA target action date.

Myfembree is described as the first and only once-daily oral treatment approved by FDA for heavy menstrual bleeding associated with uterine fibroids in premenopausal women.