FDA — authorised 29 April 1952
- Application: NDA008372
- Marketing authorisation holder: MALLINCKRODT IRELAND
- Local brand name: ACTHAR GEL (AUTOINJECTOR)
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ACTH in United States
FDA authorised ACTH on 29 April 1952
Marketing authorisations
FDA — authorised 16 June 1954
- Application: NDA008975
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PURIFIED CORTROPHIN GEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 September 1957
- Application: NDA010831
- Marketing authorisation holder: ORGANICS LAGRANGE
- Local brand name: CORTICOTROPIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088772
- Marketing authorisation holder: WATSON LABS
- Local brand name: CORTICOTROPIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Frequently asked questions
Is ACTH approved in United States?
Yes. FDA authorised it on 29 April 1952; FDA authorised it on 16 June 1954; FDA authorised it on 12 September 1957.
Who is the marketing authorisation holder for ACTH in United States?
MALLINCKRODT IRELAND holds the US marketing authorisation.