Aurobindo Pharma’s subsidiary Eugia Pharma Specialities announced on Friday that it has gained permission from the US Food and Drug Administration for Cyclophosphamide injection, which is used in the treatment of many kinds of cancer. Aurobindo Pharma announced in a regulatory filing that its subsidiary “Eugia Pharma Specialities Ltd has received a 505(b)(2) NDA approval from the US Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vial.”
The product will be available in ready-to-use injection preparation, it added.
“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 Pharma said.
According to IQVIA, the approved product has an addressable market size of USD 170 million for the twelve months ending June 2021, it added.
Cyclophosphamide Injection is indicated for malignant lymphomas, multiple myeloma, leukemia, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma and carcinoma of the breast, the filing said.
This is the 19th product to be approved (including 3 tentative approvals) for Eugia. Aurobindo now has a total of 482 abbreviated new drug application (ANDA) approvals (453 final approvals and 29 tentative approvals) from the USFDA, it added.
Shares of Aurobindo Pharma were trading at Rs 709 per scrip on BSE, up 1.56 per cent from its previous close.
