FDA — authorised 28 December 1992
- Application: NDA020080
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: IMITREX
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Imitrex in United States
FDA authorised Imitrex on 28 December 1992
Marketing authorisations
FDA — authorised 28 December 1992
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
FDA — authorised 1 June 1995
- Application: NDA020132
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: IMITREX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1997
- Application: NDA020626
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: IMITREX
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 19 February 2016
- Application: ANDA204841
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: SUMATRIPTAN
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 25 January 2019
- Application: NDA210884
- Marketing authorisation holder: TONIX MEDS
- Local brand name: TOSYMRA
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 21 September 2020
- Application: ANDA213465
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: SUMATRIPTAN
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 21 September 2020
- Application: ANDA213650
- Marketing authorisation holder: PERRIGO UK FINCO
- Local brand name: SUMATRIPTAN
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 17 February 2021
- Application: ANDA208967
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: SUMATRIPTAN
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 22 February 2021
- Application: ANDA214209
- Marketing authorisation holder: CIPLA
- Local brand name: SUMATRIPTAN
- Indication: SPRAY — NASAL
- Status: approved
Imitrex 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 Imitrex approved in United States?
Yes. FDA authorised it on 28 December 1992; FDA authorised it on 28 December 1992; FDA authorised it on 1 June 1995.
Who is the marketing authorisation holder for Imitrex in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.