Epivir

Treats human immunodeficiency virus type 1 (HIV‑1) infection. NDA 20564, held by Viiv Hlthcare. Lamivudine.

As of Nov 13, 2026, NDA 20564 (Epivir), held by Viiv Hlthcare, was first approved by FDA on Nov 22, 2004, with 32 approved supplements and 0 published complete response letters.

First approved: Nov 22, 2004
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use:

The dosage of this product is for HIV‑1 and not for HBV.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below


Jul 20, 2016	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 23, 2015	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Feb 1, 2008	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 22, 2004	Original applicationNew molecular entity	Approved	None posted
Jun 24, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 23, 1999	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review
Apr 11, 1997	Supplement 2Efficacy (new indication or use) · Priority review	Approved	None posted
Nov 17, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Products

2 strengths and forms


Epivir150MG · tablet;oral	Lamivudine	RxReference drug
Epivir300MG · tablet;oral	Lamivudine	RxReference drug

All 34 submissions, including labeling and manufacturing supplements


May 10, 2019	Supplement 39Labeling · Standard review	Approved	Label Letter
Apr 27, 2018	Supplement 38Labeling · Standard review	Approved	Label Letter
Sep 25, 2017	Supplement 37Labeling · Standard review	Approved	Label
Jul 20, 2016	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 30, 2015	Supplement 35Labeling · Standard review	Approved	Label Letter
Mar 23, 2015	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Feb 19, 2015	Supplement 34Labeling · Standard review	Approved	Letter Label
Dec 18, 2012	Supplement 32Manufacturing	Approved	None posted
Nov 18, 2011	Supplement 31Labeling	Approved	Label Letter
Feb 1, 2008	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 25, 2006	Supplement 26Labeling · Standard review	Approved	Letter Label
Jun 13, 2006	Supplement 24Labeling · Standard review	Approved	Review Letter Label
Nov 22, 2004	Supplement 20Labeling · Standard review	Approved	Review Label Letter
Nov 22, 2004	Original applicationNew molecular entity	Approved	None posted
Sep 29, 2004	Supplement 21Labeling · Standard review	Approved	Letter Label
Nov 13, 2003	Supplement 19Labeling · Standard review	Approved	Label Letter
Oct 8, 2002	Supplement 14Labeling · Standard review	Approved	Label Letter
Sep 13, 2002	Supplement 17Manufacturing	Approved	Review
Jun 24, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 1, 2002	Supplement 16Labeling · Standard review	Approved	Letter
Jun 19, 2001	Supplement 13Labeling · Standard review	Approved	None posted
Mar 6, 2001	Supplement 12Labeling · Standard review	Approved	Review Letter
Jan 5, 2001	Supplement 11Labeling · Standard review	Approved	None posted
Mar 23, 1999	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review
Mar 8, 1999	Supplement 10Labeling · Standard review	Approved	None posted
Mar 8, 1999	Supplement 9Labeling · Standard review	Approved	None posted
Nov 5, 1998	Supplement 8Manufacturing	Approved	None posted
Feb 3, 1998	Supplement 5Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 6Labeling · Standard review	Approved	None posted
Dec 15, 1997	Supplement 4Labeling · Standard review	Approved	None posted
Oct 31, 1997	Supplement 3Manufacturing	Approved	None posted
Apr 11, 1997	Supplement 2Efficacy (new indication or use) · Priority review	Approved	None posted
Jul 31, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Nov 17, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20564
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