Glenmark Gets CDSCO panel nod to market FDC of Bilastine, Dextromethorphan, Phenylephrine Syrup
New Delhi: Citing that the proposed fixed-dose combination (FDC) of Bilastine 3.3mg/5ml plus Dextromethorphan Hydrobromide 10mg/5ml plus Phenylephrine Hydrochloride 5mg/5ml syrup should not be given to children below 12 years of age for more than 7 days, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug major Glenmark to manufacture and market the proposed FDC.
This came after the drug major Glenmark presented their proposal along with the Phase III clinical trial report before the committee.
This approval is subject to the condition that the proposed FDC should not be given to children below 12 years of age for more than 7 days. In accordance with this, the expert panel advised that the firm should mention the said warning on the label and package insert/ promotional literature of the drug product.
Bilastine is an antihistamine which is used to treat allergies. It works by blocking the effects of a chemical messenger known as "histamine," which is naturally involved in allergic reactions. In short, it helps to relieve the discomfort and unpleasant symptoms that occur due to allergic conditions, like blocked/runny/itchy nose, red/watery eyes, and skin rashes.
Dextromethorphan Hydrobromide is an anti-tussive (relieve cough) medication primarily used to treat dry cough. It works by blocking the cough receptor present in the brain, which is known to cause cough.
Phenylephrine is an alpha-1 adrenergic agonist that mediates vasoconstriction and mydriasis depending on the route and location of administration. Systemic exposure to phenylephrine also leads to agonism of alpha-1 adrenergic receptors, raising systolic and diastolic pressure as well as peripheral vascular resistance. Increased blood pressure stimulates the vagus nerve, causing reflex bradycardia.
At the recent SEC meeting for the Pulmonary held on 7 November 2023, the expert panel reviewed the proposal along with the Phase III clinical trial report of the FDC pulmonary drug Bilastine plus Dextromethorphan Hydrobromide plus Phenylephrine Hydrochloride syrup presented by the drug major Glenmark Pharmaceutical.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed FDC with the condition that the proposed FDC should not be given to children below 12 years of age for more than 7 days.
Accordingly, the expert panel noted that the firm should mention the said warning on the label and package insert/promotional literature of the drug product.
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