Justify dose of Bilastine: CDSCO Panel tells Glenmark on FDC of Bilastine, Dextromethorphan ,Phenylephrine Syrup

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New Delhi: Rejecting the pharmaceuticals major Glenmark proposal for bioequivalence (BE) study waiver of fixed dose combination drug Bilastine 3.3mg plus Dextromethorphan Hydrobromide 10mg plus Phenylephrine Hydrochloride 5mg Syrup, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to justify the dose of Bilastine in the proposed FDC for further review by the committee.
This came after the firm presented the Phase III clinical trial protocol and requested for BE study waiver before the committee.
Bilastine is an anti-histamine 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 occurred due to allergic conditions, like blocked/runny/itchy nose, red/watery eyes, and skin rashes.
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