Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats multiple myeloma. Sold as Velcade, Bortezomib. Every FDA application for this active ingredient: 8 branded and 22 generic.
As of Nov 15, 2026, FDA lists 30 applications for Bortezomib (sold as Velcade, Bortezomib), first approved May 13, 2003, with 14 new uses approved and 6 published complete response letters.
First approved: May 13, 2003
Applications: 30
New uses approved: 14
Complete response letters: 6
Medicare spending, 2025: $10.2M
First approved in the EU: Apr 26, 2004
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
VelcadeA drug with a new indication and a new dosage for the treatment of systemic AL amyloidosis. · Janssen Pharmaceutical K.K. · Aug 25, 2021
VelcadeA drug with a new dosage indicated for the treatment of multiple myeloma. · Janssen Pharmaceutical K.K. · Aug 22, 2019 · Review report
VelcadeA drug with a new additional indication and a new dosage indicated for the treatment of Waldenströ m's macroglobulinemia and lymphoplasmacytic lymphoma. · Janssen Pharmaceutical K.K. · Mar 23, 2018
VelcadeA drug with a new additional indication and a new dosage for the treatment of patients with mantle cell lymphoma. · Janssen Pharmaceutical K.K. · Jun 26, 2015
VelcadeA drug with a new route of administration indicated for the treatment of multiple myeloma. · Janssen Pharmaceutical K.K. · Dec 21, 2012
VelcadeA drug with a new indication and a new dosage for the treatment of multiple myeloma. · Janssen Pharmaceutical K.K. · Sep 16, 2011
Clinical Trials
197 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
BortezomibProduct Quality, Labeling, Ann T Farrell
Approved
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Fresenius Kabi USA
Apotex
Zydus Pharms
Eugia Pharma
Baxter Hlthcare Corp
Accord Hlthcare