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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 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.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.