Ranbaxy Laboratories Limited (Ranbaxy) has received approval from the US Food and Drug Administration to manufacture and market Loratadine Syrup (Loratadine Oral Solution, USP), 5 mg/5 mL that is available to patients as an OTC product.

The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent to that of the reference listed drug, Claritin Syrup, 5 mg/5mL, of Schering Corporation. Loratadine is the generic equivalent of Schering's long-acting tricyclic antihistamine agent Claritin, which has total market sales of $13.5 million, a release from Ranbaxy said.

Loratadine is indicated for the temporary relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients two years of age or older.

"It will be available in September 2004 to all private label customers that consists of drug chains, independent retail outlets, mass merchandisers, food combination outlets, and wholesalers," according to Sandeep Parekh, vice president of Sales and Marketing for Ohm Laboratories Inc. (Ohm).

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 to the US healthcare system.