FDA — authorised 14 March 1997
- Marketing authorisation holder: AGOURON
- Status: approved
🇺🇸 Viracept in United States
FDA authorised Viracept on 14 March 1997
Marketing authorisations
FDA — authorised 14 March 1997
- Application: NDA020779
- Marketing authorisation holder: AGOURON PHARMS
- Local brand name: VIRACEPT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 March 1997
- Application: NDA020778
- Marketing authorisation holder: AGOURON PHARMS
- Local brand name: VIRACEPT
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 30 April 2003
- Application: NDA021503
- Marketing authorisation holder: AGOURON PHARMS
- Local brand name: VIRACEPT
- Indication: TABLET — ORAL
- Status: approved
Viracept in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Viracept approved in United States?
Yes. FDA authorised it on 14 March 1997; FDA authorised it on 14 March 1997; FDA authorised it on 14 March 1997.
Who is the marketing authorisation holder for Viracept in United States?
AGOURON holds the US marketing authorisation.