Faslodex

For endocrine therapy. NDA 21344, held by Astrazeneca. Fulvestrant.

As of Nov 14, 2026, NDA 21344 (Faslodex), held by Astrazeneca, was first approved by FDA on Apr 25, 2002, with 30 approved supplements and 0 published complete response letters.

First approved: Apr 25, 2002
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Monotherapy FASLODEX is indicated for the treatment of:

Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy FASLODEX is indicated for the treatment of:
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


Jul 28, 2020	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 13, 2020	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 21, 2019	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 11, 2019	Supplement 37Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 5, 2018	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 14, 2017	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 25, 2017	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 2, 2016	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 9, 2012	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 17, 2011	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Medical Review
Sep 9, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 24, 2003	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 25, 2002	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Products

2 strengths and forms


Faslodex250MG/5ML (50MG/ML) · solution;intramuscular	Fulvestrant	RxReference drug
Faslodex125MG/2.5ML (50MG/ML) · solution;intramuscular	Fulvestrant	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Jan 19, 2021	Supplement 44Labeling · Standard review	Approved	Letter Label
Jul 28, 2020	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 13, 2020	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 21, 2019	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 20, 2019	Supplement 39Labeling · Standard review	Approved	Letter Label
Mar 11, 2019	Supplement 37Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 5, 2018	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 14, 2017	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 25, 2017	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 24, 2017	Supplement 33Labeling · Standard review	Approved	Label Letter
Oct 31, 2016	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 26, 2016	Supplement 31Labeling · Standard review	Approved	Letter
Jul 12, 2016	Supplement 29Labeling · Standard review	Approved	Review Letter Label
May 19, 2016	Supplement 27Labeling · Standard review	Approved	Label Letter
Mar 2, 2016	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 1, 2016	Supplement 25Labeling · Standard review	Approved	Letter Label
Aug 25, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 30, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Oct 8, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 8, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 9, 2012	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Nov 9, 2012	Supplement 19Labeling · Standard review	Approved	Letter Label
Jul 13, 2012	Supplement 18Labeling · Standard review	Approved	Label Letter
Sep 26, 2011	Supplement 15Labeling	Approved	Letter Label
Sep 26, 2011	Supplement 14Labeling · Standard review	Approved	Letter Label
May 17, 2011	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Medical Review
Sep 9, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 9, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Aug 2, 2005	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 24, 2003	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 25, 2002	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 21344
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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