FDA — authorised 29 June 1998
- Marketing authorisation holder: MERCK
- Status: approved
🇺🇸 Maxalt in United States
FDA authorised Maxalt on 29 June 1998
Marketing authorisations
FDA — authorised 12 August 2010
- Application: NDA020864
- Marketing authorisation holder: ORGANON LLC
- Indication: Labeling
- Status: approved
FDA — authorised 16 December 2011
- Application: NDA020865
- Marketing authorisation holder: ORGANON
- Indication: Labeling
- Status: approved
FDA — authorised 29 January 2020
- Application: ANDA201914
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 21 September 2020
- Application: ANDA201967
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 30 January 2025
- Application: NDA215431
- Marketing authorisation holder: AXSOME
- Indication: Type 4 - New Combination
- Status: approved
The FDA approved Maxalt, a product of AXSOME, for a new combination indication on 30 January 2025. This approval was granted under the standard expedited pathway. The application number for this approval is NDA215431.
Maxalt 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 Maxalt approved in United States?
Yes. FDA authorised it on 29 June 1998; FDA authorised it on 12 August 2010; FDA authorised it on 16 December 2011.
Who is the marketing authorisation holder for Maxalt in United States?
MERCK holds the US marketing authorisation.