Lexiva

NDA 21548, held by Viiv Hlthcare. Fosamprenavir Calcium.

As of Nov 14, 2026, NDA 21548 (Lexiva), held by Viiv Hlthcare, was first approved by FDA on Oct 20, 2003, with 31 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2003
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below


Apr 27, 2012	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Oct 12, 2007	Supplement 13Efficacy (new indication or use)	Approved	Letter Label
Oct 20, 2003	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
LexivaEQ 700MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fosamprenavir Calcium	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


Mar 28, 2019	Supplement 41Labeling · Standard review	Approved	Label Letter
Dec 1, 2017	Supplement 40Labeling · Standard review	Approved	Label Letter
Sep 15, 2016	Supplement 39Labeling	Approved	Label Letter
Mar 22, 2016	Supplement 37Labeling · Standard review	Approved	Letter Label
Mar 10, 2016	Supplement 38Manufacturing · Standard review	Approved	None posted
Jul 17, 2015	Supplement 35Labeling · Standard review	Approved	Label Letter
Mar 27, 2015	Supplement 36Labeling	Approved	Label Letter
Oct 29, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Aug 28, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 5, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Feb 12, 2013	Supplement 31Labeling · Standard review	Approved	Label Letter
Apr 27, 2012	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Feb 17, 2012	Supplement 29Labeling	Approved	Letter Label
May 10, 2011	Supplement 26Labeling · Standard review	Approved	Label Letter
Apr 26, 2010	Supplement 24Labeling	Approved	Label Letter
Sep 11, 2009	Supplement 21Labeling · Standard review	Approved	Letter Label
Apr 14, 2009	Supplement 20Labeling · Standard review	Approved	Letter
Apr 30, 2008	Supplement 19Labeling · Standard review	Approved	Letter
Mar 5, 2008	Supplement 17Labeling · Standard review	Approved	Label Letter
Feb 20, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 14, 2007	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 13, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 12, 2007	Supplement 13Efficacy (new indication or use)	Approved	Letter Label
Feb 7, 2007	Supplement 10Labeling · Standard review	Approved	Label Letter
Nov 14, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 7, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
May 11, 2006	Supplement 8Labeling · Standard review	Approved	Letter Label
Mar 10, 2006	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 10, 2005	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 13, 2005	Supplement 4Labeling · Standard review	Approved	Label Letter
Nov 29, 2004	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 20, 2003	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21548
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