Healthcare Industry News:  Ranbaxy Laboratories 

Biopharmaceuticals Generics FDA

 News Release - April 12, 2007

Ranbaxy Receives FDA Approval To Market Loratadine Antihistamine Tablets

PRINCETON, N.J., April 12 (HSMN NewsFeed) -- Ohm Laboratories Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U. S. Food and Drug Administration to manufacture and commercialize its Loratadine Orally Disintegrating Tablets, 10mg. The antihistamine previously made the switch from the prescription to the OTC market. The Division of Bioequivalence has determined Ranbaxy's Loratadine Orally Disintegrating Tablets, 10 mg, to be bioequivalent to the reference listed drug, Claritin® Reditabs®, 10 mg, of Schering Plough Healthcare Products. Loratadine is a long-acting antihistamine agent, which, in the orally disintegrating form, has annual sales of $58.7 million.

Loratadine is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, itchy watery eyes due to hay fever or other respiratory allergies in adults and children six years of age and older.

"With Loratadine, Ohm will be launching another OTC product offering that represents a molecule with value and utility, marketed in the private label or store brand segment of the U.S. healthcare system. This will provide greater access to a product with a proven track record of clinical success as a non- sedating antihistamine, made available at an affordable cost to retail/wholesale/healthcare trade classes, and ultimately the OTC consumer market. Product will be available during the later part of June of this year," according to Robert Haywood, Senior Director of OTC Sales and Marketing, Ohm Laboratories.

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 9 countries.

Claritin® Reditabs® is a registered trademark of Schering Plough Healthcare Products

Source: Ranbaxy Laboratories

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