Ohm Laboratories Inc (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received approval from the U. S. Food and Drug Administration to manufacture and commercialize its Abbreviated New Drug Application (ANDA) for Loratadine 10 mg Tablets that have made the switch from the prescription to the OTC market. The Division of Bioequivalence has determined Ranbaxy's Loratadine Tablets, 10 mg, to be bioequivalent to the listed drug, Claritin Tablets, 10 mg, of Schering Corporation.

Loratadine is the generic equivalent of Schering-Plough's long-acting tricyclic antihistamine agent Claritin, which has combined (prescription and over-the-counter) annual sales of $944 million (IMS - MAT: June 2003).

Loratadine is indicated for the 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.

Product will be launched immediately into the OTC store brand market and will be available to pharmacies, including the retail pharmacy market that consists of chain and independent pharmacies, mass merchandisers, food combination outlets, and wholesalers.

According to Dipak Chattaraj, President of RPI, "Ohm will be participating in the launch of the first approved version of an OTC, non-sedating antihistamine drug that will be 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 that will be made available at an affordable cost to patients and health payors. Through planning and implementation, we will enjoy the privilege of being one of the first generic companies to challenge and be granted approval to market a product that will be of value to patients and clinicians of the U.S. healthcare system."