FDA — authorised 14 March 1997
- Application: NDA020778
- Marketing authorisation holder: AGOURON PHARMS
- Local brand name: VIRACEPT
- Indication: POWDER — ORAL
- Status: approved
🇺🇸 Nelfinavir (NFV) in United States
FDA authorised Nelfinavir (NFV) on 14 March 1997 · 8 US adverse-event reports
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 30 April 2003
- Application: NDA021503
- Marketing authorisation holder: AGOURON PHARMS
- Local brand name: VIRACEPT
- Indication: TABLET — ORAL
- Status: approved
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: 23 April 2025 – 23 April 2026
- Total reports: 8
Most-reported reactions
- Foetal Exposure During Pregnancy — 2 reports (25%)
- Hiv Infection — 2 reports (25%)
- Human Immunodeficiency Virus Transmission — 2 reports (25%)
- Caesarean Section — 1 report (12.5%)
- Drug Resistance — 1 report (12.5%)
Nelfinavir (NFV) 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 Nelfinavir (NFV) approved in United States?
Yes. FDA authorised it on 14 March 1997; FDA authorised it on 14 March 1997; FDA authorised it on 30 April 2003.
Who is the marketing authorisation holder for Nelfinavir (NFV) in United States?
AGOURON PHARMS holds the US marketing authorisation.