Ranbaxy Laboratories Limited (RLL) has received approval from the US Food and Drug Administration to manufacture and market carvedilol tablets, 3.125 mg, 6.25 mg, 12.5, and 25 mg. The office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug coreg tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg, respectively, of GlaxoSmithKline. Total annual market sales for Carvedilol tablets were $1.6 bn.
Carvedilol is indicated for the treatment of mild-to-severe heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitor, and digitalis. Carvedilol is also indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction, as well as in the management of essential hypertension, alone or in combination with other antihypertensive agents.
"We are pleased to receive this FDA approval for carvedilol tablets that will add depth and breadth to our product line of medications used in cardiovascular diseases. This approval further represents yet another approval in 2007 that expands our product portfolio of affordable generic alternatives. Tablets will be manufactured at our Ohm Laboratories facility in New Brunswick, New Jersey, and launched in to all classes of trade early in the fourth quarter of 2007 under the RPI label," according to Jim Meehan, vice president of sales and distribution for RPI, USA.