FDA News

Ranbaxy Receives FDA Approval To Market Loratadine Antihistamine Tablets

(April 12, 2007)-- Ohm Laboratories announced 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 (IRI - MAT: December 2006).

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.

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