Abraxane

Treats breast cancer after failure of combination chemotherapy for metastatic disease or…. NDA 21660, held by Bristol-Myers. Paclitaxel.

As of Nov 14, 2026, NDA 21660 (Abraxane), held by Bristol-Myers, was first approved by FDA on Jan 7, 2005, with 21 approved supplements and 0 published complete response letters.

First approved: Jan 7, 2005
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ABRAXANE is a microtubule inhibitor indicated for the treatment of:

Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Dec 6, 2019	Supplement 46Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Sep 6, 2013	Supplement 37Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 11, 2012	Supplement 31Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 15, 2007	Supplement 10Efficacy (new indication or use)	Approved	Review Letter Label
Jan 7, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Pediatric Written Request

Products

1 strengths and forms

Product	Active ingredient	Marketing
Abraxane100MG/VIAL · powder;intravenous	Paclitaxel	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Aug 25, 2020	Supplement 47Labeling · Standard review	Approved	Letter Label
Dec 6, 2019	Supplement 46Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Aug 16, 2018	Supplement 45Labeling · Standard review	Approved	Letter Label
Mar 24, 2016	Supplement 43Manufacturing · Standard review	Approved	None posted
Nov 2, 2015	Supplement 42Manufacturing · Standard review	Approved	None posted
Jul 21, 2015	Supplement 41Labeling · Standard review	Approved	Letter Label
Dec 11, 2014	Supplement 40Labeling · Standard review	Approved	Label Letter
Apr 28, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Oct 30, 2013	Supplement 38Labeling · Standard review	Approved	Letter Label
Sep 6, 2013	Supplement 37Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jun 7, 2013	Supplement 36Labeling · Standard review	Approved	Label Letter
Dec 10, 2012	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 11, 2012	Supplement 31Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 28, 2012	Supplement 35Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 34Labeling · Standard review	Approved	Label Letter
Dec 23, 2011	Supplement 29Labeling	Approved	Review Label Letter
Dec 23, 2011	Supplement 26Labeling	Approved	Review Label Letter
Dec 23, 2011	Supplement 25Labeling	Approved	Review Label Letter
Jun 26, 2009	Supplement 22Labeling · Standard review	Approved	Review Letter Label
Jul 1, 2008	Supplement 13Labeling · Standard review	Approved	Review Label Letter
Feb 15, 2007	Supplement 10Efficacy (new indication or use)	Approved	Review Letter Label
Jan 7, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Pediatric Written Request

Identifiers

Application: NDA 21660
Drugs@FDA: Overview at FDA
Company: Bristol Myers

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