Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL (1 ml, 5 ml and 30 ml vials). This product is expected to be launched by Q4 FY2015-16. 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.
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 twelve months ending September 2015.
Aurobindo now has 17 ANDAs (including one tentative approval) approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products. The company now has a total of 220 ANDA approvals (192 Final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
