labels: industry - general, pharmaceuticals, ranbaxy
Ranbaxy receives US FDA nod to market loperamide hydrochloride and simethicone tabletsnews
Loperamide hydrochlori
11 September 2006
Ranbaxy Laboratories Ltd has received US FDA approval to manufacture and market loperamide hydrochloride and simethicone tablets, 2 mg, 125 mg (OTC). The Office of Generic Drugs, US FDA, has determined the generic loperamide hydrochloride and simethicone tablets, to be bioequivalent to the reference listed drug (RLD) Imodium advanced caplets, 2 mg and 125 mg (OTC) of McNeil Consumer and Specialty Pharmaceuticals, a Division of McNeil PPC, Inc.

Loperamide hydrochloride and simethicone tablets are indicated for controlling symptoms of diarrhea plus bloating, pressure, and cramps commonly referred to as gas. Total OTC market sales of the product were $25.3 million (IRI - MAT: June 2006).

According to Robert Haywood, senior director, OTC sales and marketing, 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 US retailers and wholesalers. Ohm plans to ship when sufficient supplies are produced to meet the demands of the marketplace."

US-based Ohm Laboratories Inc., based in North Brunswick, New Jersey, is a wholly owned subsidiary of the Company, India's largest pharmaceutical Company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the U.S. healthcare system.


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Ranbaxy receives US FDA nod to market loperamide hydrochloride and simethicone tablets