FDA — authorised 26 May 2021
- Application: NDA214846
- Marketing authorisation holder: SUMITOMO PHARMA AM
- Local brand name: MYFEMBREE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Relugolix + Estradiol + Norethindrone Acetate in United States
FDA authorised Relugolix + Estradiol + Norethindrone Acetate on 26 May 2021
Marketing authorisation
Frequently asked questions
Is Relugolix + Estradiol + Norethindrone Acetate approved in United States?
Yes. FDA authorised it on 26 May 2021.
Who is the marketing authorisation holder for Relugolix + Estradiol + Norethindrone Acetate in United States?
SUMITOMO PHARMA AM holds the US marketing authorisation.