FDA — authorised 22 May 2020
- Application: NDA208352
- Marketing authorisation holder: EVOFEM INC
- Local brand name: PHEXXI
- Indication: GEL — VAGINAL
- Status: approved
FDA authorised Phexxi on 22 May 2020
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 22 May 2020; FDA has authorised it.
EVOFEM INC holds the US marketing authorisation.