Feb. 27, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets.
These generic torsemide tablets are therapeutic equivalents of Hoffman la Roche’s Demadex® Tablets and include four strengths: 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately USD 35 million in the US.
Torsemide is a diuretic, indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
The Company expects to reach the market shortly with these products.
Demadex® is a registered trademark of Roche Therapeutics, Inc.
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