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FDA Grants Approval to Nevakar Injectables for Cyclophosphamide RTD Solution

Monday, July 03, 2023

Nevakar Injectables Inc., a biopharmaceutical company focused on developing sterile injectable products for critical and ambulatory care, announced today that the U.S. Food and Drug Administration (FDA) has approved their new drug application (NDA) for Cyclophosphamide Injection. The approved medication can be used in combination therapy for various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.

Sriram Ramanathan, MS, MBA, the Chief Executive Officer of Nevakar Injectables, expressed their delight at receiving FDA approval and emphasized the importance of the cyclophosphamide ready-to-dilute multi-dose injection in oncology therapy. The product is available in two configurations: 500 mg / 2.5 mL and 1 gram / 5 mL vials, providing healthcare providers with flexibility based on patient needs. The formulation is designed to be simple and free of unnecessary additives, benefiting both providers and patients by minimizing waste, simplifying preparation, and reducing the risk of dosing errors and product exposure.

Ramanathan also highlighted that this marks Nevakar's third NDA approval in the past year, showcasing the company's commitment to innovation, scalability, and contributing valuable solutions to the healthcare system.

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