New Delhi: Aurobindo Pharma Limited has announced that it has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Aurobindo Pharma receives USFDA Approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC), which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Delsym Extended- Release Oral Suspension, 30 mg/5 mL, of RB Health (US) LLC.
The product will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the company, and will be launched in Q2FY27.
The approved product has an estimated market size of US$ 138 million for the twelve months ending February 2026, according to Nielsen. Aurobindo Pharma now has a total of 580 ANDA approvals (557 final approvals and 23 tentative approvals) from USFDA.
Dextromethorphan Polistirex Extended-Release Oral Suspension (OTC) temporarily relieves (1) cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants (2) the impulse to cough to help one get to sleep.
