FDA — authorised 10 August 2018
- Application: NDA209627
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: ANNOVERA
- Indication: RING — VAGINAL
- Status: approved
FDA authorised Segesterone Acetate and Ethinyl Estradiol on 10 August 2018
Yes. FDA authorised it on 10 August 2018.
MAYNE PHARMA holds the US marketing authorisation.