FDA — authorised 16 November 2016
- Application: NDA208470
- Marketing authorisation holder: MILLICENT
- Local brand name: INTRAROSA
- Indication: INSERT — VAGINAL
- Status: approved
🇺🇸 Prasterone (DHEA), Micronized in United States
FDA authorised Prasterone (DHEA), Micronized on 16 November 2016
Marketing authorisation
Prasterone (DHEA), Micronized in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Reproductive/Fertility approved in United States
Frequently asked questions
Is Prasterone (DHEA), Micronized approved in United States?
Yes. FDA authorised it on 16 November 2016.
Who is the marketing authorisation holder for Prasterone (DHEA), Micronized in United States?
MILLICENT holds the US marketing authorisation.