EU approves S-P's desloratadine for CIU

The European Union has granted marketing authorization toSchering-Plough for the highly-potent antihistamine desloratadine, in 5mg tablet formulation, as a once-daily, non-sedating treatment for the symptoms of chronic idiopathic urticaria.

Desloratadine is a follow-up to S-P's Claritin (loratadine) for the treatment of seasonal allergic rhinitis which was approved in the EU for this indication earlier this year (Marketletter January 22), and is marketed under the brand names Aerius and Neoclaritin. The firm has also received an approvable letter from the US Food and Drug Administration for SAR, and separate marketing applications have been submitted in the USA, where it is known as Clarinex, for the treatment of CIU and allergic rhinitis, but faces problems in this market because the Food and Drug Administration has refused final approval until manufacturing problems are addressed (Marketletter July 2)