From USFDA
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 US$31 million for the twelve months ending September 2015 according to IMS.
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