Akums Drugs Montelukast Sodium, Bilastine FDC gets CDSCO panel okay for phase 3 trial
New Delhi: The Subject Expert Committee functional under the Central Drugs Standard Control Organization (CDSCO) has given its clearance to Akums Drugs for conducting phase III clinical trial of Fixed Dose Combination (FDC) of Montelukast Sodium and Bilastine.
The approval came after the firm presented the revised Phase III Clinical trial protocol before the committee at the 51st SEC committee meeting (Pulmonary), conducted on 08.06.2021 at CDSCO.
The revised phase III protocol was constructed in accordance with a previous SEC recommendation dated February 26, 2021 and March 1, 2021, in which the drugmaker, Akums Drugs, was instructed to submit the revised protocol for further consideration by the committee, based on the following points:
1. Firm should add one more arm of Montelukast to the study to prove superiority or alternatively can conduct noninferiority trial by using another approved FDC as comparator.
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