FDA — authorised 10 February 1987
- Application: NDA016750
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 COSYNTROPIN in United States
FDA authorised COSYNTROPIN on 10 February 1987 · 146 US adverse-event reports
Marketing authorisations
FDA — authorised 27 November 2024
- Application: ANDA202147
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
The FDA approved COSYNTROPIN, a synthetic analogue of adrenocorticotropic hormone (ACTH), for use in the United States. The approval was granted to SANDOZ, the marketing authorisation holder, on 27 November 2024. The approval was based on a standard application pathway.
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: 20 April 2025 – 20 April 2026
- Total reports: 146
Most-reported reactions
- Foetal Growth Restriction — 24 reports (16.44%)
- Foetal Exposure During Pregnancy — 23 reports (15.75%)
- Hypoglycaemia — 18 reports (12.33%)
- Dyspnoea — 15 reports (10.27%)
- Hypotension — 12 reports (8.22%)
- Nausea — 12 reports (8.22%)
- Hyperkalaemia — 11 reports (7.53%)
- Pneumonia — 11 reports (7.53%)
- Off Label Use — 10 reports (6.85%)
- Rash — 10 reports (6.85%)
COSYNTROPIN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is COSYNTROPIN approved in United States?
Yes. FDA authorised it on 10 February 1987; FDA authorised it on 27 November 2024.
Who is the marketing authorisation holder for COSYNTROPIN in United States?
AMPHASTAR PHARMS INC holds the US marketing authorisation.