FDA
- Application: ANDA218832
- Marketing authorisation holder: ANNORA PHARMA PRIVATE LIMITED
- Local brand name: PITOLISANT
- Indication: TABLET
- Status: approved
🇺🇸 Pitolisant tablet in United States
Pitolisant tablet (Pitolisant tablet) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA218846
- Marketing authorisation holder: LUPIN LIMITED
- Local brand name: PITOLISANT
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA218873
- Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
- Local brand name: PITOLISANT
- Indication: TABLET — FILM COATED
- Status: approved
FDA
- Application: ANDA218495
- Marketing authorisation holder: NOVITIUM PHARMA LLC
- Local brand name: PITOLISANT
- Indication: TABLET
- Status: approved
Pitolisant tablet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neurology approved in United States
Frequently asked questions
Is Pitolisant tablet approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Pitolisant tablet in United States?
ANNORA PHARMA PRIVATE LIMITED holds the US marketing authorisation.