Durg maker Aurobindo Pharma on Wednesday said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL (1 mL, 5 mL and 30 mL vials) in USA.
According to a statement issued by the city-based drug maker, the product is expected to be launched by the last quarter of the current fiscal. "The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL, of Luitpold Pharmaceuticals Inc," it said.
Dexamethasone Sodium Phosphate Injection is used in the treatment of various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders and skin diseases. The approved product has an estimated market size of $31 million for the 12 months ending September, 2015, according to IMS.
Aurobindo now has 17 ANDAs (including one tentative approval) approved out of Unit IV formulation facility in Hyderabad for manufacturing general injectable products. "Aurobindo now has a total of 220 ANDA approvals (192 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA," the statement added.