FDA — authorised 29 May 2018
- Application: NDA208564
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: IMVEXXY
- Indication: INSERT — VAGINAL
- Status: approved
FDA authorised Imvexxy on 29 May 2018
Yes. FDA authorised it on 29 May 2018; FDA has authorised it.
MAYNE PHARMA holds the US marketing authorisation.