Justify dose of Bilastine: CDSCO Panel tells Glenmark on FDC of Bilastine, Dextromethorphan ,Phenylephrine Syrup
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...
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.
At the recent SEC for Pulmonary held on 28.04.2022, the expert panel reviewed the Phase III clinical trial protocol and request for the BE study waiver in detail.
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