FDA — authorised 18 August 2015
- Marketing authorisation holder: SPROUT PHARMACEUTICALS INC
- Status: approved
🇺🇸 Addyi in United States
FDA authorised Addyi on 18 August 2015
Marketing authorisations
FDA — authorised 18 August 2015
- Application: NDA022526
- Marketing authorisation holder: SPROUT PHARMS
- Local brand name: ADDYI
- Indication: TABLET — ORAL
- Status: approved
Addyi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Addyi approved in United States?
Yes. FDA authorised it on 18 August 2015; FDA authorised it on 18 August 2015.
Who is the marketing authorisation holder for Addyi in United States?
SPROUT PHARMACEUTICALS INC holds the US marketing authorisation.