Boruzu FDA Approval History
FDA Approved: Yes (First approved September 5, 2024)
Brand name: Boruzu
Generic name: bortezomib
Dosage form: Injection
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma, Mantle Cell Lymphoma
Boruzu (bortezomib) is a ready-to-use injectable proteasome inhibitor for the treatment of multiple myeloma and mantle cell lymphoma.
- Boruzu is a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration.
- This new ready-to-use oncology product reduces the compounding preparation steps typically required with the administration of Velcade, a lyophilized powder form of bortezomib requiring reconstitution before use.
- Shilpa developed the molecule and Amneal will manufacture and commercialize the product.
- The most commonly reported adverse reactions for Boruzu in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia.
Development timeline for Boruzu
| Date | Article |
|---|---|
| Sep 5, 2024 | Approval FDA Approves Boruzu (bortezomib) Ready-to-Use Injection for Multiple Myeloma and Mantle Cell Lymphoma |
Further information
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