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Published on 9/21/2006 in the Prospect News Biotech Daily.

Ranbaxy gets FDA approval to sell Furosemide tablets

By Elaine Rigoli

Tampa, Fla., Sept. 21 - Ranbaxy Laboratories, Ltd. has received approval from the Food and Drug Administration to manufacture and market Furosemide tablets USP, 20 mg, 40 mg and 80 mg.

The FDA's Office of Generic Drugs determined the Haryana, India-based pharmaceutical company's formulations to be bioequivalent and have the same therapeutic effect as that of the reference-listed drug Lasix tablets, 20 mg, 40 mg and 80 mg, respectively, of Aventis Pharmaceuticals, Inc.

Annual market sales are about $70 million, according to a news release.

Furosemide is indicated in adults, infants and children for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome.


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