RANBAXY WINS APPROVAL TO MARKET GENERIC IMODIUM

Ranbaxy Laboratories announced it has received approval from the FDA to manufacture and market generic loperamide hydrochloride and simethicone tablets, 2 mg/125 mg, for OTC use. The Office of Generic Drugs has determined Ranbaxy's drug to be bioequivalent to the reference-listed drug Imodium Advanced Caplets, made by McNeil Consumer and Specialty Pharmaceuticals. The drug is indicated for controlling symptoms of diarrhea plus bloating, pressure and cramps commonly referred to as gas.

Ohm Laboratories, a U.S.-based subsidiary of Ranbaxy, India's largest pharmaceutical company, will handle the sale and distribution of the product in the U.S.

The generic Imodium "will be marketed on a 180-day exclusive basis in the private label/store brand segment of major U.S. retailers and wholesalers," according to Robert Haywood, senior director of OTC sales and marketing at Ohm.