Ranbaxy receives approval to mkt Loperamide Hydrochloride

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Ranbaxy receives approval to mkt Loperamide Hydrochloride

Ranbaxy receives USFDA approval to market loperamide hydrochloride and simethicone tablets

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Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC).  The Office of Generic Drugs, U.S. Food and Drug Administration, has determined Ranbaxy's Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC) to be bioequivalent to the reference listed drug (RLD) Imodium^Ò Advanced Caplets, 2 mg/125 mg (OTC) of McNeil Consumer and Specialty Pharmaceuticals, a Division of McNeil PPC, Inc. (McNeil).

Loperamide Hydrochloride and Simethicone Tablets (OTC) are indicated for controlling symptoms of diarrhea plus bloating, pressure, and cramps commonly referred to as gas.  Total sales of $25.3 million (IRI - MAT:  June 2006) were achieved for this product that is sold in the OTC market.

According to Robert Haywood, Senior Director of OTC Sales and Marketing of Ohm Laboratories Inc., "Ohm will again be a leading participant in the launch of another successful and proven Loperamide formulation.   This will be marketed on a 180-day exclusive basis in the private label/store brand segment of major U.S. retailers and wholesalers.  Ohm plans to ship when sufficient supplies are produced to meet the demands of the marketplace."

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