FDA Approves Boruzu Ready-to-Use Injection for Multiple Myeloma and Mantle Cell Lymphoma
Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. Food and Drug Administration (FDA) approval of Boruzu, a new presentation of bortezomib for ready-to-use subcutaneous or intravenous (IV) administration. This new oncology product reduces the compounding preparation steps typically required with administration. This product references the branded product Velcade , a lyophilized powder requiring reconstitution before use.
- Boruzu (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma.
- Shilpa developed the molecule and Amneal will manufacture and commercialize the product. Boruzu is expected to launch with a unique J-code in the second quarter of 2025.
Source: Amneal Pharmaceuticals, Inc.
