Aurobindo Pharma arm receives regulator's nod to make, market Azacitidine in US
Jan 04, 2023
Hyderabad (Telangana) [India], January 4 : Aurobindo Pharma on Wednesday said its wholly-owned subsidiary -- Eugia Pharma Specialities -- received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Azacitidine for injection 100 mg single-dose vial.
Azacitidine is in a class of medications called demethylation agents. These agents work by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.
The product is expected to be launched this month, according to the statement from Aurobindo Pharma. The approved product has an estimated market size of around USD 46 million for the 12 months ending November 2022, according to IQVIA.
The pharma firm said this was the 153rd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile speciality products.
