Sciele Pharma, Inc., of Atlanta and Novo Nordisk Inc., of Denmark, have announced approval for PrandiMet (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also called Prandin) and the insulin sensitizer metformin for the treatment of type 2 diabetes.
PrandiMet has been approved to lower blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled adequately by meglitinide and/or metformin.
FDA approved the new combination based on data showing that PrandiMet 1 mg/500 mg and 2 mg/500 mg resulted in similar bioequivalence to the administration of corresponding doses of repaglinide and metformin HCl as individual tablets.
“With PrandiMet, physicians will have a simplified option for Prandin and metformin combination therapy,” said Novo Nordisk president Jerzy Gruhn.
Sciele Pharma will exclusively market PrandiMet to physicians in the United States, and expects the drug to be available to physicians and patients in the second half of 2008.