Famvir

NDA 20363, held by Novartis. Famciclovir.

As of Nov 13, 2026, NDA 20363 (Famvir), held by Novartis, was first approved by FDA on Jun 29, 1994, with 35 approved supplements and 0 published complete response letters.

First approved: Jun 29, 1994
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Feb 9, 2012	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 31, 2011	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 24, 2009	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Written Request
Jul 28, 2006	Supplement 28Efficacy (new indication or use)	Approved	Letter Label
Jul 28, 2006	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 12, 1998	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter
Sep 17, 1997	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 11, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 29, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Famvir250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Famciclovir	DiscontinuedReference drug
Famvir500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Famciclovir	DiscontinuedReference drug
Famvir125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Famciclovir	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Dec 18, 2018	Supplement 50Labeling · Standard review	Approved	Letter Label
Dec 9, 2016	Supplement 49Manufacturing · Standard review	Approved	None posted
Nov 1, 2016	Supplement 48Manufacturing · Standard review	Approved	None posted
Sep 16, 2016	Supplement 47Labeling · Standard review	Approved	Letter Label
Oct 19, 2015	Supplement 45Manufacturing · Standard review	Approved	None posted
Sep 10, 2015	Supplement 46Manufacturing · Standard review	Approved	None posted
May 14, 2015	Supplement 44Manufacturing · Standard review	Approved	None posted
Jun 25, 2014	Supplement 41Manufacturing · Standard review	Approved	None posted
Apr 24, 2013	Supplement 42Labeling · Standard review	Approved	Label Letter
Feb 9, 2012	Supplement 40Labeling · Standard review	Approved	Letter Label
Feb 9, 2012	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 31, 2011	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 24, 2009	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Written Request
Dec 22, 2008	Supplement 34Labeling · Standard review	Approved	Label Letter
Jun 6, 2007	Supplement 32Manufacturing	Approved	None posted
Jul 28, 2006	Supplement 28Efficacy (new indication or use)	Approved	Letter Label
Jul 28, 2006	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 22, 2006	Supplement 26Labeling · Standard review	Approved	Letter Label
Aug 6, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 29, 2001	Supplement 19Labeling · Standard review	Approved	Review Label Letter
Feb 2, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 12, 1998	Supplement 16Labeling · Standard review	Approved	Letter
Jun 12, 1998	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 12, 1998	Supplement 10Labeling · Standard review	Approved	Letter
Mar 26, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 17, 1997	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 15, 1997	Supplement 13Labeling · Standard review	Approved	None posted
Jan 31, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 13, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Jul 29, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Jul 29, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Apr 26, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Dec 11, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 8, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 27, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 29, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20363
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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