Justify rationality for FDC Sitagliptin, Lobeglitazon: CDSCO Panel Tells Synokem Pharma
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New Delhi: In line with the drug major Synokem pharmaceutical's proposal for deliberation of bioequivalence (BE) and phase III clinical trial protocol of the fixed-dose combination (FDC) Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined that the firm should justify rationality for combining this FDC and its significant benefit.
In addition, the expert panel suggested that the firm should explain the justification for the dose titration, international approval status, and the scientific literature available from a peer-reviewed journal in support of combining this FDC.
This came after the firm presented its proposal and requested for deliberation of BE & Phase III CT protocol for Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets.
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