FDA — authorised 6 May 2009
- Application: NDA022192
- Marketing authorisation holder: VANDA PHARMS INC
- Local brand name: FANAPT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Fanapt in United States
FDA authorised Fanapt on 6 May 2009
Marketing authorisations
FDA — authorised 28 November 2016
- Application: ANDA207231
- Marketing authorisation holder: INVENTIA
- Local brand name: ILOPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2019
- Application: ANDA207098
- Marketing authorisation holder: TARO
- Local brand name: ILOPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2022
- Application: ANDA206890
- Marketing authorisation holder: LUPIN
- Local brand name: ILOPERIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA207409
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: ILOPERIDONE
- Indication: TABLET — ORAL
- Status: approved
Fanapt 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 Fanapt approved in United States?
Yes. FDA authorised it on 6 May 2009; FDA authorised it on 28 November 2016; FDA authorised it on 22 July 2019.
Who is the marketing authorisation holder for Fanapt in United States?
VANDA PHARMS INC holds the US marketing authorisation.