Is Nelfinavir approved by the US FDA?

Drugs@FDA lists 3 application product lines for Nelfinavir, including VIRACEPT (Prescription); VIRACEPT (Prescription); VIRACEPT (Discontinued).

Is Nelfinavir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Nelfinavir.

Are there safety signals or safety updates for Nelfinavir?

US FDA: 3 entries (latest 2021-03-24).

Active substance

Nelfinavir

US FDA 3
EMA 1
Safety 3

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VIRACEPT	EQ 250MG BASE	tablet · oral	AGOURON PHARMS	Prescription	14 Mar 1997
VIRACEPT	EQ 625MG BASE	tablet · oral	AGOURON PHARMS	Prescription	30 Apr 2003
VIRACEPT	EQ 50MG BASE/SCOOPFUL	powder · oral	AGOURON PHARMS	Discontinued	14 Mar 1997

EMA European Union — centrally authorised medicines

Viracept Roche Registration Ltd. · Withdrawn · authorised 22 Jan 1998 · ATC J05AE04

Therapeutic indication (EMA)

Viracept is indicated in antiretroviral combination treatment of human-immunodeficiency-virus (HIV-1)-infected adults, adolescents and children of three years of age and older. In protease-inhibitor (PI)-experienced patients, the choice of nelfinavir should be based on individual viral resistance testing and treatment history.

Safety signals and safety-related labeling changes

US FDA 24 Mar 2021 VIRACEPT — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Mar 2021 VIRACEPT — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Mar 2021 VIRACEPT — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for nelfinavir →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.