Healthcare Industry News: Ranbaxy Laboratories
News Release - September 11, 2006
Ranbaxy Receives FDA Approval to Market Loperamide Hydrochloride and Simethicone Tablets
First to File Status provides Ranbaxy with 180-day Marketing ExclusivityPRINCETON, N.J., Sept. 11 (HSMN NewsFeed) -- Ohm Laboratories Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL) of New Delhi, India, announced today that RLL 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® 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, "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."
Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited ("RLL"), 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.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 8 countries.
* Imodium® Advanced Caplets, is a registered trademark of McNeil Consumer and Specialty Pharmaceuticals, a Division of McNeil PPC, Inc. (McNeil)
Source: Ranbaxy Laboratories
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