PRINCETON, NJ, (August 23, 2004) — Ohm Laboratories, Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has received approval from the U.S. 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.
“We are now in a position to be able to offer an additional dosage form of this non-drowsy antihistamine that is available to patients as an OTC product. It will be available in September 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.
Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited, India’s largest pharmaceutical company.