FDA — authorised 28 May 2021
- Application: NDA213378
- Marketing authorisation holder: ALKERMES INC
- Local brand name: LYBALVI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 LYBALVI in United States
FDA authorised LYBALVI on 28 May 2021
Marketing authorisation
Other Psychiatry approved in United States
Frequently asked questions
Is LYBALVI approved in United States?
Yes. FDA authorised it on 28 May 2021.
Who is the marketing authorisation holder for LYBALVI in United States?
ALKERMES INC holds the US marketing authorisation.