FDA — authorised 22 July 1953
- Application: NDA008951
- Marketing authorisation holder: LILLY
- Local brand name: PAGITANE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Pagitane in United States
FDA authorised Pagitane on 22 July 1953
Marketing authorisations
FDA
- Marketing authorisation holder: LILLY
- Status: approved
Pagitane in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Pagitane approved in United States?
Yes. FDA authorised it on 22 July 1953; FDA has authorised it.
Who is the marketing authorisation holder for Pagitane in United States?
LILLY holds the US marketing authorisation.