Source – Nevakar Injectables
On July 3, 2023 the FDA has approved a new drug application (NDA) for 200-mg/mL vials of cyclophosphamide injection, which can be used in combination therapy to treat various types of cancers, including malignant lymphoma, multiple myeloma, and different forms of leukemia. This approval comes from Nevakar Injectables.
“We are delighted to receive FDA approval and believe that cyclophosphamide ready-to-dilute multi dose injection serves a very important need in oncology therapy. The product is available in two configurations, 500 mg / 2.5 mL and 1 gram / 5 mL vials to provide the health care providers with flexibility to use based on patient needs. Our simple and elegant formulation contains no unnecessary additives and benefits both providers and patients, as it minimizes waste, is easy to prepare, and reduces the risk of dosing error and product exposure. This is Nevakar’s third NDA approval in the past one year highlighting our rapid pace of innovation, scalability, experience and commitment to developing products that add value to the health care system.”
– Sriram Ramanathan, MS, MBA, chief executive officer of Nevakar Injectables
Previously, only solid formulations of cyclophosphamide were available commercially. However, a patent for stable liquid formulations of cyclophosphamide allowed for the development of this new injection.
Cyclophosphamide undergoes biological transformation in the liver and activates alkylating metabolites through a mixed function microsomal oxidase system. These metabolites are responsible for cross-linking the DNA of tumor cells.
While cyclophosphamide can be effective as a standalone treatment for certain cancers, it is more commonly used in combination with other antineoplastic drugs, either concurrently or sequentially.
Cyclophosphamide injection is indicated for the treatment of various malignancies, including Ann Arbor stage III and IV malignant lymphomas, Hodgkin lymphoma, nodular or diffuse lymphocytic lymphoma, mixed-cell-type lymphoma, Burkitt lymphoma, multiple myeloma, leukemias (including chronic lymphocytic leukemia, chronic granulocytic leukemia, acute myelogenous and monocytic leukemia, and acute lymphoblastic leukemia in pediatric patients), advanced mycosis fungoides, disseminated neuroblastoma, ovarian adenocarcinoma, retinoblastoma, and breast carcinoma.
