FDA — authorised 17 November 1997
- Application: NDA020839
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: PLAVIX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 12-month clopidogrel therapy in United States
FDA authorised 12-month clopidogrel therapy on 17 November 1997
Marketing authorisations
FDA
- Status: approved
12-month clopidogrel therapy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is 12-month clopidogrel therapy approved in United States?
Yes. FDA authorised it on 17 November 1997; FDA has authorised it.
Who is the marketing authorisation holder for 12-month clopidogrel therapy in United States?
SANOFI AVENTIS US holds the US marketing authorisation.