Velcade

NDA 21602, held by Takeda Pharms USA. Bortezomib.

As of Nov 14, 2026, NDA 21602 (Velcade), held by Takeda Pharms USA, was first approved by FDA on May 13, 2003, with 30 approved supplements and 0 published complete response letters.

First approved: May 13, 2003
Review: Priority
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VELCADE is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma treatment of adult patients with mantle cell lymphoma 1.1 Multiple Myeloma VELCADE is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Apr 25, 2019	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 14, 2015	Supplement 42Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Amendment 2 Pediatric Amendment 1
Oct 8, 2014	Supplement 40Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 8, 2014	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 23, 2012	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 1, 2011	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 30, 2009	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 30, 2009	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 20, 2008	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 10, 2007	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 8, 2006	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Mar 25, 2005	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 13, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Velcade3.5MG/VIAL · injectable;intravenous, subcutaneous	Bortezomib	RxReference drug

All 31 submissions, including labeling and manufacturing supplements


Nov 4, 2021	Supplement 46Labeling · Standard review	Approved	Letter Label
Oct 25, 2021	Supplement 45Labeling · Standard review	Approved	Letter Label
Apr 25, 2019	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 9, 2017	Supplement 43Labeling · Standard review	Approved	Label Letter
Sep 14, 2015	Supplement 42Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Amendment 2 Pediatric Amendment 1
Aug 20, 2015	Supplement 41Manufacturing · Priority review	Approved	None posted
Oct 8, 2014	Supplement 40Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 8, 2014	Supplement 39Manufacturing · Priority review	Approved	None posted
Aug 8, 2014	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 13, 2014	Supplement 37Manufacturing · Priority review	Approved	None posted
Aug 5, 2013	Supplement 36Manufacturing · Priority review	Approved	None posted
Aug 2, 2013	Supplement 35Manufacturing · Priority review	Approved	None posted
Apr 1, 2013	Supplement 33Manufacturing · Priority review	Approved	None posted
Oct 26, 2012	Supplement 32Labeling	Approved	Letter Label
Oct 26, 2012	Supplement 31Labeling	Approved	Letter Label
Jan 23, 2012	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 1, 2011	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 1, 2011	Supplement 29Labeling	Approved	Label Letter
Apr 7, 2011	Supplement 28Labeling	Approved	None posted
Dec 3, 2010	Supplement 23Labeling	Approved	Letter Label
Dec 30, 2009	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 30, 2009	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 24, 2009	Supplement 18Manufacturing	Approved	Letter
Jun 20, 2008	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 10, 2007	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 8, 2006	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 31, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 8, 2005	Supplement 7Labeling · Standard review	Approved	Letter
Mar 25, 2005	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 25, 2004	Supplement 4Labeling · Standard review	Approved	Letter
May 13, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21602
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

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