FDA — authorised 3 July 1950
- Application: NDA007504
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ACTHAR
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 H.P. Acthar Gel in United States
FDA authorised H.P. Acthar Gel on 3 July 1950 · 50 US adverse-event reports
Marketing authorisations
FDA — authorised 14 March 1952
- Application: NDA008317
- Marketing authorisation holder: PARKEDALE
- Local brand name: ACTH
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 April 1952
- Application: NDA008372
- Marketing authorisation holder: MALLINCKRODT IRELAND
- Local brand name: ACTHAR GEL
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 50
Most-reported reactions
- Dyspnoea — 7 reports (14%)
- Atrial Fibrillation — 6 reports (12%)
- Anaemia — 5 reports (10%)
- Dehydration — 5 reports (10%)
- Hypertension — 5 reports (10%)
- Renal Failure Acute — 5 reports (10%)
- Vomiting — 5 reports (10%)
- Abdominal Pain — 4 reports (8%)
- Fluid Retention — 4 reports (8%)
- Oedema — 4 reports (8%)
Other Immunology / Rheumatology approved in United States
Frequently asked questions
Is H.P. Acthar Gel approved in United States?
Yes. FDA authorised it on 3 July 1950; FDA authorised it on 14 March 1952; FDA authorised it on 29 April 1952.
Who is the marketing authorisation holder for H.P. Acthar Gel in United States?
SANOFI AVENTIS US holds the US marketing authorisation.