Amneal Pharmaceuticals and Shilpa Medicare Limited announced U.S. Food and Drug Administration approval of BORUZU(TM), a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration. BORUZU, a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade(R), a lyophilized powder requiring reconstitution before use. 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.
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