Fuzeon

As of Nov 14, 2026, NDA 21481 (Fuzeon), held by Roche, was first approved by FDA on Mar 13, 2003, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 13, 2003
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Apr 28, 2011	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 29, 2006	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 15, 2004	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 13, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fuzeon90MG/VIAL · injectable;subcutaneous	Enfuvirtide	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Aug 15, 2019	Supplement 33Labeling · Standard review	Approved	Letter Label
Dec 27, 2018	Supplement 32Labeling · Standard review	Approved	Label Letter
Dec 2, 2015	Supplement 30Labeling · Standard review	Approved	Label Letter
Jun 19, 2015	Supplement 29Manufacturing · Priority review	Approved	None posted
Sep 22, 2014	Supplement 21Manufacturing · Priority review	Approved	None posted
Oct 31, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
Mar 13, 2013	Supplement 26Manufacturing · Priority review	Approved	None posted
Aug 10, 2012	Supplement 25Labeling	Approved	Label Letter
Apr 28, 2011	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 22, 2009	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 16, 2008	Supplement 15Labeling · Standard review	Approved	Letter
Jan 19, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 20, 2006	Supplement 12Labeling · Standard review	Approved	Letter Label
Sep 29, 2006	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 12, 2005	Supplement 7Labeling · Standard review	Approved	Letter Label
Jun 29, 2005	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 15, 2004	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 13, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21481
Drugs@FDA: Overview at FDA
Company: Roche

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