Aurobindo Pharma has received final approval from the USFDA to market Dextromethorphan Polistirex Extended-Release Oral Suspension (30 mg/5 mL), an over-the-counter (OTC) medication. Bioequivalent to the reference drug Delsym, this product addresses cough symptoms related to the common cold and other irritants. The drug is set for a commercial launch in Q2FY27 and targets a market valued at approximately US$ 138 million based on data for the twelve months ending February 2026.
New Product Approval
Aurobindo Pharma has secured final USFDA approval to manufacture and market its Dextromethorphan Polistirex Extended-Release Oral Suspension (30 mg/5 mL). This OTC medication is bioequivalent and therapeutically equivalent to the reference listed drug, Delsym, produced by RB Health (US) LLC. This milestone brings the company’s total portfolio to 580 ANDA approvals, comprising 557 final and 23 tentative approvals.
Manufacturing and Market Outlook
The medication will be produced at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the company. The commercial launch is scheduled for Q2FY27. According to recent market analysis, this product competes in a segment with an estimated market size of US$ 138 million for the period ending February 2026.
Product Application
Dextromethorphan Polistirex is indicated as an OTC treatment to provide temporary relief from coughs caused by minor throat and bronchial irritation associated with the common cold or inhaled irritants. It also assists in suppressing the impulse to cough, helping patients improve their sleep quality.
Source: BSE
