Prescription medicine
Bortezomib Brand names: Velcade, Boruzu
Bortezomib (Velcade) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 22 generic labelers.
- Generic listed
Check it at the source: the bortezomib FDA label on DailyMed (effective February 27, 2023, Hospira, Inc.); the NDA 21602 record on Drugs@FDA; every bortezomib label on DailyMed.
Highlights of the record
FDA label of February 27, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBortezomib for Injection is a proteasome inhibitor indicated for:
Treatment of adult patients with multiple myeloma.
Forms and strengths
- 1 mg
- 2.5 mg
- 3.5 mg
- 1 mg/ml
- 3.5 mg/3.5ml
- 3.5 mg/1.4ml
Injection (powder) (lyophilized) for solution; injection.
On the market
- Earliest approval on file
- May 13, 2003 Velcade, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first May 2, 2022; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 22 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- September 23, 2042 Bortezomib injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2019 0 Class I among all firms' recalls; latest June 24, 2026
- FAERS reports
- 88,912 through July 30, 2026
What is bortezomib used for?
From the label: indications and usageBortezomib for Injection is a proteasome inhibitor indicated for:
Treatment of adult patients with multiple myeloma. ( 1.1 )
Treatment of adult patients with mantle cell lymphoma. ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
Conditions named in the indications of bortezomib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Proteasome Inhibitor.
Source: FDA drug label (BORTEZOMIB), Hospira, Inc., effective February 27, 2023 (SPL set 9fdf6169-699f-40eb-bda1-760253062b3c), via openFDA; the full label on DailyMed
Is there a generic for bortezomib (Velcade)?
The FDA approved the first generic bortezomib on May 2, 2022. 22 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists bortezomib from 22 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Velcade injection; a patent listed only for Bortezomib injection runs to September 23, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2003 earliest approval on file
- 2022 first generic approved
- 2042 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has bortezomib been recalled?
The FDA's Enforcement Report lists 3 recalls naming bortezomib since 2019: 0 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 24, 2026 | Class II | Reliance Life Sciences Private Limited | Lack of Sterility Assurance |
| January 19, 2022 | Class III | Dr. Reddy's Laboratories, Inc. | Failed stability specifications |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bortezomib label say about other medicines?
The bortezomib label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name bortezomib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclophosphamide | warnings and precautions | … (79%) ≥ 10,000/µL to < 50,000/ µL 7 1 (14%) 5 (71%) In the combination study of bortezomib with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) in previously untreated mantle cell lymphoma patients, the incidence of thrombocytopenia (≥Grade 4) was 32% vs 1% for the rituximab, cyclophosphamide … |
| Cytarabine | warnings and precautions | In a clinical trial, the first two patients given high-dose cytarabine (2 g/m 2 per day) by continuous infusion with daunorubicin and bortezomib for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. |
| Daunorubicin | warnings and precautions | In a clinical trial, the first two patients given high-dose cytarabine (2 g/m 2 per day) by continuous infusion with daunorubicin and bortezomib for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. |
| Dexamethasone | drug interactions | Interactions with Bortezomib No clinically significant drug interactions have been observed when Bortezomib for Injection was coadministered with dexamethasone, omeprazole, or melphalan in combination with prednisone [see Clinical Pharmacology (12.3) ]. |
| Doxorubicin | warnings and precautions | … to < 50,000/ µL 7 1 (14%) 5 (71%) In the combination study of bortezomib with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) in previously untreated mantle cell lymphoma patients, the incidence of thrombocytopenia (≥Grade 4) was 32% vs 1% for the rituximab, cyclophosphamide, doxorubicin … |
| Melphalan | drug interactions | Interactions with Bortezomib No clinically significant drug interactions have been observed when Bortezomib for Injection was coadministered with dexamethasone, omeprazole, or melphalan in combination with prednisone [see Clinical Pharmacology (12.3) ]. |
| Omeprazole | drug interactions | Interactions with Bortezomib No clinically significant drug interactions have been observed when Bortezomib for Injection was coadministered with dexamethasone, omeprazole, or melphalan in combination with prednisone [see Clinical Pharmacology (12.3) ]. |
| Prednisone | drug interactions | Interactions with Bortezomib No clinically significant drug interactions have been observed when Bortezomib for Injection was coadministered with dexamethasone, omeprazole, or melphalan in combination with prednisone [see Clinical Pharmacology (12.3) ]. |
| Rituximab | warnings and precautions | … 2 (14%) 11 (79%) ≥ 10,000/µL to < 50,000/ µL 7 1 (14%) 5 (71%) In the combination study of bortezomib with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) in previously untreated mantle cell lymphoma patients, the incidence of thrombocytopenia (≥Grade 4) was 32% vs 1% for the rituximab … |
| Vincristine | warnings and precautions | … the incidence of thrombocytopenia (≥Grade 4) was 32% vs 1% for the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) arm as shown in Table 12 . |
Other labels that name bortezomib
Source: FDA drug label (BORTEZOMIB), Hospira, Inc., effective February 27, 2023 (SPL set 9fdf6169-699f-40eb-bda1-760253062b3c), via openFDA; the full label on DailyMed
What do FAERS reports show for bortezomib?
The FDA Adverse Event Reporting System holds 88,912 reports that list bortezomib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,068 are coded as a death and 28,333 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other proteasome inhibitors
- the pharmacologic class, with prices and generics
- Bortezomib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other