FDA — authorised 14 May 1998
- Marketing authorisation holder: MEDICURE
- Status: approved
🇺🇸 Aggrastat in United States
FDA authorised Aggrastat on 14 May 1998
Marketing authorisations
FDA — authorised 14 May 1998
- Application: NDA020913
- Marketing authorisation holder: MEDICURE
- Local brand name: AGGRASTAT
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 14 May 1998
- Application: NDA020912
- Marketing authorisation holder: MEDICURE
- Local brand name: AGGRASTAT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 April 2021
- Application: ANDA206888
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 1 May 2023
- Application: ANDA216379
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 24 July 2023
- Application: ANDA213947
- Marketing authorisation holder: NEXUS
- Status: approved
Aggrastat in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Aggrastat approved in United States?
Yes. FDA authorised it on 14 May 1998; FDA authorised it on 14 May 1998; FDA authorised it on 14 May 1998.
Who is the marketing authorisation holder for Aggrastat in United States?
MEDICURE holds the US marketing authorisation.