Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received approval from the U.S. Food and Drug Administration to market Flecainide Acetate Tablets USP, in 50 mg, 100 mg, and 150 mg strengths. The Division of Bioequivalence has determined Ranbaxy's Flecainide Acetate Tablets USP, 50 mg, 100 mg, and 150 mg, to be bioequivalent and, therefore, therapeutically equivalent to the listed drug Tambocor Tablets, 50 mg, 100 mg, and 150 mg, respectively, of 3M Pharmaceuticals Inc.
In patients without structural heart disease, Tambocor is indicated for the prevention of paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. Tambocor™ is also indicated for the prevention of documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. In 2002, the total sales of Flecainide Acetate Tablets totaled $105.6 million (IMS - MAT, Dec. 2002).
Product is expected to be available through wholesalers and other distribution outlets to dispensing pharmacies throughout the United States. According to Dipak Chattaraj, President of Ranbaxy Pharmaceuticals Inc, "With the addition of Flecainide Acetate Tablets, Ranbaxy's generic product line is expanding to meet the clinical needs of the U.S. Healthcare System that includes prescribers, patients and health plans with a generic alternative for this cardiovascular product. Flecainide will be manufactured in the U.S. at Ohm Laboratories, our facility located in North Brunswick, NJ."