Aurobindo Pharma arm gets USFDA okay for Cyclophosphamide Injection
Hyderabad: Aurobindo Pharma Limited today announced that the company's subsidiary Eugia Pharma Specialities Ltd. has received a 505(b)(2) NDA approval from the U.S.Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. Aurobindo's product will be available in ready-to-use (RTU) injection preparation. The product shall be launched in the...
Hyderabad: Aurobindo Pharma Limited today announced that the company's subsidiary Eugia Pharma Specialities Ltd. has received a 505(b)(2) NDA approval from the U.S.Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials.
Aurobindo's product will be available in ready-to-use (RTU) injection preparation. The product shall be launched in the US market in the near term and will be manufactured in Eugia's manufacturing facility in India.
Aurobindo's Cyclophosphamide Injection is indicated for Malignant lymphomas, Multiple myeloma, Leukemias, Mycosis fungoides (advanced disease), Neuroblastoma (disseminated disease), Adenocarcinoma of the ovary, Retinoblastoma, Carcinoma of the breast.
The approved product has an addressable market size of US$ 170 million for the twelve months ending June 2021 according to IQVIA. This is the 19th product to be approved (including 3 tentative approvals) for Eugia. Aurobindo now has a total of 482 ANDA approvals (453 Final approvals and 29 tentative approvals) from USFDA.
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