FDA accepts Accu-Break drug application for Coumadin bioequivalent

The Food and Drug Administration (FDA) accepted Accu-Break Pharmaceutical's New Drug Application (NDA) for warfarin potassium Thursday.

The product is the bioequivalent of Coumadin, a prescription medicine from Bristol-Myers Squibb company that is used to prevent and treat blood clots in the legs and lungs as well as costs associated with heart-valve replacement or an irregular, rapid heartbeat known as atrial fibrillation. It can lower the risk of death, heart attacks, strokes and clots moving to other body parts.

As a company known for developing tablet technologies that enable accurate and customized dosing, Accu-Break Pharmaceutical offers two tablet versions of warfarin potassium: the 4 mg tablet can split into 1 mg quarter doses and the 5 mg tablet can be divided into half doses. The vitamin K antagonist features bilayer tablet technology with a backbone drug-free layer that allows for accurate dose adjustments.

"Our first NDA filing represents an important milestone in the history of the company," Accu-Break Pharmaceutical Executive Chairman Elliot Hahn said. "We recognize that patients taking the widely prescribed anticoagulant warfarin frequently split tablets. The ABP technology makes it safer and easier for them to obtain an appropriate dose when splitting tablets.”

Accu-Break Pharmaceutical asserts that based on IMS data, the two tablets of warfarin potassium address the nine doses of Coumadin that are currently available on the market.