Lexiva

NDA 22116, held by Viiv Hlthcare. Fosamprenavir Calcium.

As of Nov 13, 2026, NDA 22116 (Lexiva), held by Viiv Hlthcare, was first approved by FDA on Jun 14, 2007, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2007
Review: Priority
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Apr 27, 2012	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 14, 2007	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
LexivaEQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · suspension;oral	Fosamprenavir Calcium	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Mar 28, 2019	Supplement 25Labeling · Standard review	Approved	Label Letter
Dec 1, 2017	Supplement 24Labeling · Standard review	Approved	Label Letter
Sep 15, 2016	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 22, 2016	Supplement 21Labeling · Standard review	Approved	Letter Label
Jul 17, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Mar 27, 2015	Supplement 20Labeling	Approved	Label Letter
Feb 12, 2013	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 27, 2012	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 17, 2012	Supplement 13Labeling	Approved	Letter Label
May 10, 2011	Supplement 10Labeling · Standard review	Approved	Label Letter
Apr 26, 2010	Supplement 8Labeling	Approved	Label Letter
Sep 11, 2009	Supplement 5Labeling · Standard review	Approved	Letter Label
Apr 14, 2009	Supplement 4Labeling · Standard review	Approved	Letter
Apr 30, 2008	Supplement 3Labeling · Standard review	Approved	Letter
Mar 5, 2008	Supplement 1Labeling · Standard review	Approved	Label Letter
Jun 14, 2007	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 22116
Drugs@FDA: Overview at FDA
Company: ViiV Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters