Relenza

Treats acute, uncomplicated influenza type A and B infections. NDA 21036, held by Glaxosmithkline. Zanamivir.

As of Nov 14, 2026, NDA 21036 (Relenza), held by Glaxosmithkline, was first approved by FDA on Jul 26, 1999, with 25 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1999
Review: Priority
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. Prophylaxis of influenza in patients aged 5 years and older. Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in:

Individuals with underlying airways disease. Not proven effective for:
Treatment in individuals with underlying airways disease.
Prophylaxis in nursing home residents. Not a substitute for annual influenza vaccination.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below


Mar 29, 2006	Supplement 9Efficacy (new indication or use) · Priority review	Approved	None posted
Mar 29, 2006	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Apr 26, 2000	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jul 26, 1999	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Relenza5MG · powder;inhalation	Zanamivir	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Oct 24, 2023	Supplement 34Labeling · Standard review	Approved	Label Letter
Oct 19, 2021	Supplement 32Labeling · Standard review	Approved	Letter Label
Jun 21, 2018	Supplement 30Labeling · Standard review	Approved	Label Letter
Jul 21, 2016	Supplement 29Manufacturing · Priority review	Approved	None posted
Feb 15, 2013	Supplement 28Manufacturing · Priority review	Approved	None posted
Dec 20, 2011	Supplement 27Labeling · Standard review	Approved	Label Letter
Dec 9, 2010	Supplement 25Labeling · Standard review	Approved	Letter Label
May 4, 2010	Supplement 24Labeling	Approved	Letter
Mar 24, 2010	Supplement 19Labeling	Approved	Letter Label
May 8, 2009	Supplement 18Manufacturing · Priority review	Approved	Letter
Oct 2, 2008	Supplement 17Labeling · Standard review	Approved	Label Letter
Feb 21, 2008	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 13, 2007	Supplement 15Manufacturing · Priority review	Approved	Letter
Sep 7, 2007	Supplement 12Labeling · Standard review	Approved	Label Letter
Jun 27, 2007	Supplement 14Manufacturing · Priority review	Approved	Letter
Mar 9, 2007	Supplement 13Labeling · Standard review	Approved	Letter
Nov 22, 2006	Supplement 10Labeling · Priority review	Approved	Letter
Mar 29, 2006	Supplement 9Efficacy (new indication or use) · Priority review	Approved	None posted
Mar 29, 2006	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Mar 25, 2004	Supplement 7Labeling · Priority review	Approved	Letter
Aug 6, 2003	Supplement 6Labeling · Standard review	Approved	Letter Label
Aug 5, 2003	Supplement 5Labeling · Standard review	Approved	Letter Label
May 18, 2001	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 27, 2001	Supplement 4Labeling · Standard review	Approved	Label
Apr 26, 2000	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jul 26, 1999	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Identifiers

Application: NDA 21036
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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