CDSCO panel rejects Emcure Voglibose, Vildagliptin FDC citing dosage schedule incompatibility between ingredients
New Delhi: Citing dosage schedule incompatibility between the ingredients, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has rejected to approve Emcure's Fixed-Dose Combination (FDC) drug of Voglibose and a popular diabetes drug Vildagliptin.
Pointing out that there is no rationality for the FDC, the panel rejected the drugmaker's submission as Vildagliptin is a Twice Daily medication while Voglibose is one more dosage ie. Thrice Daily. Thus, prompting adequacy in the proposal by the drugmaker.
Headquartered at Pune, Emcure had moved a proposal before the CDSCO committee for approval of its FDC Voglibose 0.2mg/0.3mg and Vildagliptin 50 mg/50 mg tablets.
The drugmaker sells Voglibose under the brand name Stabose 0.3mg Tablet, which is an anti-diabetic medication. It inhibits the intestinal enzymes that cause the breakdown of complex sugars into simple sugars such as glucose. This prevents blood glucose from rising very high after meals.
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