Aurobindo Pharma Secures USFDA Approval for Dextromethorphan Extended-Release Oral Suspension
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market its Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC). The product is recognized as being both bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Delsym Extended-Release Oral Suspension, 30 mg/5 mL, originally marketed by RB Health (US) LLC.The approved product is scheduled for launch in Q2FY27 and will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the company.The OTC suspension is indicated to temporarily relieve minor...