FDA — authorised 12 April 1946
- Marketing authorisation holder: VALEANT
- Status: approved
🇺🇸 Migranal in United States
FDA authorised Migranal on 12 April 1946
Marketing authorisations
FDA — authorised 8 December 1997
- Application: NDA020148
- Marketing authorisation holder: BAUSCH
- Local brand name: MIGRANAL
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 9 June 2003
- Application: ANDA040453
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 2 September 2021
- Application: NDA213436
- Marketing authorisation holder: IMPEL PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 7 January 2025
- Application: ANDA216747
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Status: approved
FDA — authorised 14 May 2025
- Application: NDA215400
- Marketing authorisation holder: AMNEAL
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Migranal, a new formulation or new manufacturer of a previously approved drug, on 2025-05-14. The marketing authorisation holder is AMNEAL. This approval was granted under the standard expedited pathway.
Migranal 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 Migranal approved in United States?
Yes. FDA authorised it on 12 April 1946; FDA authorised it on 8 December 1997; FDA authorised it on 9 June 2003.
Who is the marketing authorisation holder for Migranal in United States?
VALEANT holds the US marketing authorisation.