Citing voglibose, sitagliptin incompatibility, CDSCO panel rejects Hetero Labs proposal for antidiabetic FDC drug
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New Delhi: In a setback to Hetero Labs, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has rejected its Fixed-Dose Combination (FDC) of Sitagliptin Phosphate(50mg/50mg) and Voglibose, citing dosage schedule incompatibility between the ingredients.
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor with a high selectivity that has been approved for the treatment of type 2 diabetes. It functions by competitively inhibiting the enzyme dipeptidyl peptidase 4 (DPP4), leading to higher gastrointestinal hormones glucagon-like peptide-1 (GLP-1) and Gastric inhibitory polypeptide (GIP), which improves hyperglycemia in diabetic patients by increasing serum insulin levels.
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