FDA — authorised 3 July 1950
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Acthar Gel in United States
FDA authorised Acthar Gel on 3 July 1950
Marketing authorisations
FDA — authorised 29 April 1952
- Application: NDA008372
- Marketing authorisation holder: MALLINCKRODT IRELAND
- Local brand name: ACTHAR GEL (AUTOINJECTOR)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 1954
- Application: NDA008975
- Marketing authorisation holder: ANI PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 12 September 1957
- Application: NDA010831
- Marketing authorisation holder: ORGANICS LAGRANGE
- Local brand name: CORTICOTROPIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Acthar Gel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Acthar Gel approved in United States?
Yes. FDA authorised it on 3 July 1950; FDA authorised it on 29 April 1952; FDA authorised it on 16 June 1954.
Who is the marketing authorisation holder for Acthar Gel in United States?
SANOFI AVENTIS US holds the US marketing authorisation.