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On Wednesday, Aurobindo Pharma said that it has received final approval from the US Food and Drug Administration (USFDA) for manufacturing and marketing Dexamethasone Sodium Phosphate Injection USP, 4mg/mL (1 mL, 5mL, and 30 mL vials) in USA .
The company has said in a statement that the product is expected to be launched by the last quarter of the current fiscal.
It further said that “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”.
