FDA — authorised 28 May 2021
- Marketing authorisation holder: ALKERMES INC
- Status: approved
🇺🇸 Lybalvi in United States
FDA authorised Lybalvi on 28 May 2021
Marketing authorisations
FDA — authorised 25 September 2023
- Application: NDA213378
- Marketing authorisation holder: ALKERMES INC
- Indication: Labeling
- Status: approved
Lybalvi 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 Lybalvi approved in United States?
Yes. FDA authorised it on 28 May 2021; FDA authorised it on 25 September 2023.
Who is the marketing authorisation holder for Lybalvi in United States?
ALKERMES INC holds the US marketing authorisation.