Aurobindo Pharma arm Eugia Pharma Specialities has got the U.S. FDA’s approval for Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials, which is used in the treatment of certain types of cancer.
The product will be available in ready-to-use injection preparation and is to be unveiled in the U.S. in the near term. It will be manufactured at Eugia’s manufacturing facility in India, Aurobindo Pharma said in a release on Friday. The approved product has an addressable market size of $170 million for the twelve months ending June 2021, the company said citing IQVIA numbers.
It said the subsidiary’s product has received 505(b)(2) NDA approval from the U.S. health regulator. According to the U.S. FDA, a 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use.
This is the 19th product to be approved, including three tentative approvals, for Eugia. Aurobindo now has a total of 482 ANDA approvals, consisting of 453 final approvals and 29 tentative approvals from U.S. FDA, the company said. Cyclophosphamide injection is indicated for malignant lymphomas, multiple myeloma, leukaemias, mycosis fungoides (advanced disease), neuroblastoma (disseminated disease), adenocarcinoma of the ovary, retinoblastoma and carcinoma of the breast.
