FDA — authorised 6 December 1995
- Application: NDA020628
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: INVIRASE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Saquinavir (Invirase®) in United States
FDA authorised Saquinavir (Invirase®) on 6 December 1995
Marketing authorisations
FDA — authorised 17 December 2004
- Application: NDA021785
- Marketing authorisation holder: HOFFMANN-LA ROCHE
- Local brand name: INVIRASE
- Indication: TABLET — ORAL
- Status: approved
Saquinavir (Invirase®) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Saquinavir (Invirase®) approved in United States?
Yes. FDA authorised it on 6 December 1995; FDA authorised it on 17 December 2004.
Who is the marketing authorisation holder for Saquinavir (Invirase®) in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.