Ranbaxy Laboratories on Thursday said it had received Abbreviated New Drug Application approval from the US Food and Drug Administration to manufacture and market Loratidine, a generic version of Schering Corporation's Claritin.
Loratidine is an anti-histamine indicated for relief from nasal and non-nasal symptoms of seasonal allergic rhinitis.
The drug would be launched into the Over The Counter store brand market by Ohm Laboratories Inc, a wholly-owned US subsidiary of Ranbaxy.
Commenting on the approval, Dipa Chattaraj, president and chief executive officer of Ranbaxy, US said, "Ohm will be participating in the launch of first approved version of an OTC, non-sedative anti-histamine drug. This will provide greater access to a product with a proven track record," a company statement said in New Delhi.