Quick answers
- What is Bortezomib used for?
- The FDA-approved label (Velcade, Takeda Pharmaceuticals America, Inc., August 28, 2025) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bortezomib have a boxed warning?
- No. None of the 30 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bortezomib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bortezomib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bortezomib?
- 26 companies list prescription products of Bortezomib in the FDA NDC Directory, including BluePoint Laboratories, Hospira, Inc. and Gland Pharma Limited.
What Bortezomib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Velcade, Takeda Pharmaceuticals America, Inc., effective August 28, 2025. Read the full label on DailyMed →
The FDA has 30 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 30 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- BluePoint Laboratories3 products
- Hospira, Inc.3 products
- Gland Pharma Limited2 products
- Eugia US LLC2 products
- MAIA Pharmaceuticals, Inc.2 products
- Meitheal Pharmaceuticals Inc.1 product
- Avenacy, LLC1 product
- Zydus Lifesciences Limited1 product
- Fresenius Kabi USA, LLC1 product
- Novadoz Pharmaceuticals LLC1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- Sagent Pharmaceuticals1 product
- NorthStar RxLLC1 product
- Sintetica US LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Dr. Reddy's Laboratories Inc.1 product
- Pharmascience Inc.1 product
- Somerset Therapeutics, LLC1 product
- Ningbo Shuangcheng Pharmaceutical Co., Ltd.1 product
- Apotex Corp.1 product
- Shilpa Medicare Limited1 product
- Waverley Pharma Inc1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Takeda Pharmaceuticals America, Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021602 VELCADE | Takeda Pharms USA | May 13, 2003 | 30, latest November 4, 2021 2021: Labeling · 2021: Labeling · 2019: Efficacy |
| NDA209191 BORTEZOMIB | Hospira | May 2, 2022 | 1, latest December 9, 2022 2022: Efficacy |
| NDA212782 BORTEZOMIB | Shilpa | August 26, 2024 | — |
| NDA215331 BORTEZOMIB | Maia Pharms Inc | July 27, 2022 | — |
Generic approvals (15)
- ANDA205533Apotex · May 2, 2022
- ANDA208392Pharmascience Inc · May 2, 2022
- ANDA209659Fresenius Kabi USA · May 2, 2022
- ANDA210204Zydus Pharms · May 2, 2022
- ANDA210824Qilu Pharm Hainan · May 2, 2022
- ANDA212825Eugia Pharma · May 2, 2022
- ANDA202963DR Reddys · July 26, 2022
- ANDA208460Hospira · July 26, 2022
- ANDA209622Msn · July 26, 2022
- ANDA212958Meitheal · July 26, 2022
- ANDA215011Jiangsu Hansoh Pharm · July 26, 2022
- ANDA211898Somerset Theraps LLC · October 11, 2022
- ANDA212204Hetero Labs Ltd Vi · May 3, 2024
- ANDA216528Shuangcheng · December 17, 2025
- ANDA219167Gland · January 6, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Velcade, Takeda Pharmaceuticals America, Inc., effective August 28, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →