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Ranbaxy + Cadila US FDA Nod for Carvedilol

September 6, 2007

Ranbaxy Laboratories has announced that the company has received approval from the U.S. FDA to manufacture and market carvedilol tablets, 3.125 mg, 6.25 mg, 12.5, and 25 mg. The office of generic drugs, U.S. FDA, 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 billion.

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.

Cadila Healthcare has also received an approval from the US FDA to market carvedilol tablets 3.125 mg, 6.25 mg, 12.5 mg. and 25 mg, in the US market. The drug falls in the cardiovascular segment.

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