FDA — authorised 20 December 2019
- Marketing authorisation holder: INTRA-CELLULAR
- Status: approved
🇺🇸 Caplyta in United States
FDA authorised Caplyta on 20 December 2019
Marketing authorisations
FDA — authorised 20 December 2019
- Application: NDA209500
- Marketing authorisation holder: INTRA-CELLULAR
- Local brand name: CAPLYTA
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA219085
- Marketing authorisation holder: AUROBINDO PHARMA LIMITED
- Local brand name: LUMATEPERONE
- Indication: CAPSULE
- Status: approved
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 authorised it on 20 December 2019; FDA authorised it on 20 December 2019; FDA has authorised it.
Who is the marketing authorisation holder for Caplyta in United States?
INTRA-CELLULAR holds the US marketing authorisation.