Aurobindo subsidiary Eugia gets FDA approval for Cyclophosphamide Injection
Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug Administration (FDA) for the new drug application for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials.
Cyclophosphamide Injection is indicated in the US for malignant lymphomas, multiple myeloma, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, leukemias, mycosis fungoides, and carcinoma of the breast.
The Indian pharma company said that the drug will be available in ready-to-use (RTU) injection preparation. It will be rolled out in the near term in the US market and will be manufactured at Eugia Pharma Specialities’ facility in India.
According to IQVIA, cyclophosphamide has an addressable market size of $170 million for the 12 months ending June 2021.
Cyclophosphamide Injection is the 19th product for to be approved for Eugia Pharma Specialities, while taking Aurobindo Pharma’s ANDA approvals from the FDA to 482.