Nevakar Injectables Announces FDA Approval of Cyclophosphamide RTD SolutionReady-to-dilute, multi-dose vials reduce compounding time and waste

BRIDGEWATER, NJ – July 3, 2023 – Nevakar Injectables Inc. (“Nevakar”), a biopharmaceutical company developing multiple sterile injectable products for use in the critical and ambulatory care settings, announced today that the U.S. Food and Drug Administration (“FDA”) has approved its new drug application (“NDA”) for Cyclophosphamide Injection, 200mg/mL vials for use in combination therapy for various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.

“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,” stated Sriram Ramanathan, MS, MBA, Chief Executive Officer of Nevakar Injectables. “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.”