FDA
- Status: approved
🇺🇸 Caplyta in United States
Caplyta (Caplyta) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA219200
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LUMATEPERONE
- Indication: CAPSULE
- Status: approved
FDA
- Application: ANDA219229
- Marketing authorisation holder: DR. REDDY'S LABORATORIES LIMITED
- Local brand name: LUMATEPERONE
- Indication: CAPSULE
- Status: approved
Caplyta 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 Caplyta approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Caplyta in United States?
University of Chicago is the originator. The local marketing authorisation holder may differ — check the official source linked above.