New Delhi: The Subject Expert Committee (SEC) functional under Central Drugs Standard Control Organization (CDSCO) has given its nod to Sun Pharmaceuticals for manufacturing and marketing the fixed-dose combination (FDC) of Dextromethorphan Hydrobromide 30mg and Chlorpheniramine maleate IP 4mg sustained-release Oral suspension.
However, the SEC approval came with the condition that the firm should conduct a Phase-IV clinical trial and, accordingly, the Phase-IV protocol should be submitted within 03 months from the date of approval.
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Dextromethorphan Hydrobromide & Chlorpheniramine maleate drug combination is used to relieve throat inflammation that triggers coughing, sneezing, and a runny nose.
Dextromethophan, an antitussive agent, is primarily used as a cough suppressant to relieve cough caused by mild throat and bronchial inflammation (such as that which often occurs with the flu and common cold), as well as cough caused by inhaled particle irritants.
While Chlorpheniramine is an antihistamine used to control allergies, hay fever, and the common cold.
The SEC approval for manufacturing and marketing the FDC of Dextromethorphan Hydrobromide 30mg & Chlorpheniramine maleate IP 4mg sustained-release oral suspension came after the firm presented their proposal along with the Bioequivalence (BE) study report before the committee.
The committee reviewed the proposal and noted that the FDC of Dextromethorphan Hydrobromide 10mg + Chlorphenaramine maleate 2mg per 5ml is already approved by DCGI.
After detailed deliberation, the committee recommended for grant of permission for manufacturing and marketing the proposed FDC subject to the condition that a Phase-IV clinical trial should be conducted and, accordingly, the Phase-IV protocol should be submitted within 03 months from the date of approval for review by the committee.
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