FDA to Review New Warfarin Formulation

Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.

ABP’s warfarin potassium has shown to be bioequivalent to Coumadin (warfarin sodium; Bristol-Myers Squibb). ABP believes its product meets FDA standards of “Guidance for Industry: Tablet Scoring; Nomenclature, Labeling, and Data for Evaluation” for “functional scoring.”

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Recognizing patients’ need to split tablets, ABP developed a 4mg tablet that can be split into exact 1mg quarter doses and a 5mg tablet into half doses.

Warfarin potassium is a vitamin K antagonist containing a bilayer tablet technology with a backbone drug-free layer that enables accurate dose adjustments.

For more information visit Accubreak.com.