FDA — authorised 10 August 2018
- Application: NDA209627
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: ANNOVERA
- Indication: RING — VAGINAL
- Status: approved
🇺🇸 Annovera in United States
FDA authorised Annovera on 10 August 2018
Marketing authorisations
FDA
- Marketing authorisation holder: MAYNE PHARMA
- Status: approved
Annovera in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Annovera approved in United States?
Yes. FDA authorised it on 10 August 2018; FDA has authorised it.
Who is the marketing authorisation holder for Annovera in United States?
MAYNE PHARMA holds the US marketing authorisation.