Fixed-Dose Combination Tablet Approved for Type 2 Diabetes
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