USFDA approves India-made Dexamethasone injection
Dexamethasone Sodium Phosphate injection had an estimated market size of $31 million for the twelve months till September 2015 The Dollar Business Bureau So far, Aurobindo Pharma Ltd. has acquired 17 ANDAs (including one tentative approval) approvals for manufacturing general injectable products Indian drug major Aurobindo Pharma Ltd. on Wednesday announced that it 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). "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.," Aurobindo Pharma Ltd. said in a statement. Dexamethasone Sodium Phosphate injection is used for ...
