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news.Sciele Pharma and Novo Nordisk have announced that the FDA has approved PrandiMet tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide and insulin sensitizer, metformin, for the treatment of Type 2 diabetes.
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Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet to physicians in the US. Sciele Pharma anticipates that PrandiMet will be available to physicians and patients in the US in the second half of 2008.
PrandiMet has been approved to lower the blood glucose in adult patients with Type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.
The FDA approved PrandiMet based upon data demonstrating that PrandiMet 1mg/500mg and 2mg/500mg resulted in similar bioequivalence to co-administration of corresponding doses of repaglinide and metformin HCl as individual tablets.
Patrick Fourteau, CEO of Sciele Pharma, said: “We are very pleased with approval of PrandiMet, an important new treatment option for people struggling to keep their blood glucose in control.”