Is Fosamprenavir approved by the US FDA?

Drugs@FDA lists 4 application product lines for Fosamprenavir, including FOSAMPRENAVIR CALCIUM (Prescription); FOSAMPRENAVIR CALCIUM (Prescription); LEXIVA (Discontinued); LEXIVA (Discontinued).

Is Fosamprenavir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Fosamprenavir.

Are there safety signals or safety updates for Fosamprenavir?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2019-03-28).

Active substance

Fosamprenavir

US FDA 4
EMA 1
Safety 4

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
FOSAMPRENAVIR CALCIUM	EQ 700MG BASE	tablet · oral	MYLAN	Prescription	15 Apr 2016
FOSAMPRENAVIR CALCIUM	EQ 700MG BASE	tablet · oral	SUN PHARM	Prescription	20 Nov 2019
LEXIVA	EQ 700MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	VIIV HLTHCARE	Discontinued	20 Oct 2003
LEXIVA	EQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	VIIV HLTHCARE	Discontinued	14 Jun 2007

EMA European Union — centrally authorised medicines

Telzir ViiV Healthcare BV · Withdrawn · authorised 12 Jul 2004 · ATC J05AE07

Therapeutic indication (EMA)

Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied. In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.

Safety signals and safety-related labeling changes

US FDA 28 Mar 2019 LEXIVA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Mar 2019 LEXIVA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No

All safety entries for fosamprenavir →

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.