FDA Approves Ready-to-Dilute Cyclophosphamide Injection for Various Cancers

The FDA has approved a new drug application (NDA) for 200-mg/mL vials of cyclophosphamide injection for use in combination therapy in the treatment of patients with various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.¹

“We are delighted to receive FDA approval and believe that cyclophosphamide ready-to-dilute multidose injection serves a very important need in oncology therapy,” Sriram Ramanathan, MS, MBA, chief executive officer of Nevakar Injectables, stated in a news release. “The product is available in two configurations, 500 mg/2.5 mL and 1 g/5 mL vials, to provide the healthcare providers with flexibility to use based on patient needs.”

According to a patent for stable liquid formulations of cyclophosphamide, only solid formulations of cyclophosphamide were previously commercially available.² Cyclophosphamide for injection is comprised of cyclophosphamide and at least 1 pharmaceutically acceptable inactive substance where the moisture content of the liquid formulation is less than approximately 2.0% by weight.

Malignancies that could be treated with cyclophosphamide injection include Ann Arbor stage III and IV malignant lymphomas, Hodgkin lymphoma, nodular or diffuse lymphocytic lymphoma, mixed-cell–type lymphoma, Burkitt lymphoma, multiple myeloma, leukemias, chronic lymphocytic leukemia, chronic granulocytic leukemia, acute myelogenous and monocytic leukemia, acute lymphoblastic leukemia in pediatric patients, advanced mycosis fungoides, disseminated neuroblastoma, ovarian adenocarcinoma, retinoblastoma, and breast carcinoma.

“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,” Ramanathan added.¹ “This is Nevakar’s third NDA approval in the past year, highlighting our rapid pace of innovation, scalability, experience, and commitment to developing products that add value to the health-care system.”

References

1. Nevakar Injectables announces FDA approval of cyclophosphamide RTD solution. News release. Nevakar Injectables. July 3, 2023. Accessed July 5, 2023. https://nevakarinjectables.com/news/nevakar-injectables-announces-fda-approval-of-cyclophosphamide-rtd-solution/
2. United States patent US 11,382,923 B2. July 12, 2022. Accessed July 5, 2023. https://patentimages.storage.googleapis.com/95/c8/c9/74d87eac61d263/US11382923.pdf