Ranbaxy gets FDA approval to sell generic Imodium

By Elaine Rigoli

Tampa, Fla., Sept. 11 - Ranbaxy Laboratories Ltd. said it received approval from the Food and Drug Administration to manufacture and market loperamide hydrochloride and simethicone tablets, 2 mg/125 mg, which are indicated for controlling symptoms of diarrhea plus bloating, pressure and gas.

The FDA's Office of Generic Drugs determined the company's drugs to be bioequivalent to McNeil Consumer and Specialty Pharmaceuticals' Imodium Advanced Caplets, 2 mg/125 mg. McNeil is a division of McNeil PPC, Inc.

"This will be marketed on a 180-day exclusive basis in the private label/store brand segment of major U.S. retailers and wholesalers. [We plan] to ship when sufficient supplies are produced to meet the demands of the marketplace," Robert Haywood, senior director of over-the-counter sales and marketing of Ohm Laboratories Inc., said in a Ranbaxy news release.

Ohm Laboratories is a North Brunswick, N.J.-based wholly owned subsidiary of Ranbaxy that sells and distributes pharmaceuticals. Ranbaxy is based in Haryana, India, and produces generic pharmaceutical products.

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