Drug firm Aurobindo Pharma on Friday said its arm Eugia Pharma Specialities has received approval from the US health regulator for Cyclophosphamide injection, used in the treatment of several types of cancer.
The company’s 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,” Aurobindo Pharma said in a regulatory filing.
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 $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.