Posted by Michael Wonder on 02 Jun 2022
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree
2 June 2022 - Myovant Sciences and Pfizer announced today that the U.S. FDA accepted for review a supplemental new drug application for Myfembree (relugolix 40 mg, estradiol 1 mg,and norethindrone acetate 0.5 mg).
The supplemental new drug application proposes updates to Myfembree’s United States Prescribing Information based on safety and efficacy data from the Phase 3 LIBERTY randomised withdrawal study of Myfembree in pre-menopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years.
The FDA set a target action date of 29 January 2023 for this supplemental new drug application under the Prescription Drug User Fee Act.
