S-P seeks broader usage for Clarinex

Schering-Plough has submitted a New Drug Application to the US Food andDrug Administration seeking to broaden the allergy indication for its non-sedating antihistamine, Clarinex (desloratadine) 5mg tablets. The proposed indication of allergic rhinitis would encompass both seasonal and perennial allergic rhinitis. Clarinex has already been granted an approval letter for seasonal allergic rhinitis, while a separate application for chronic idiopathic urticaria is pending at the FDA (Marketletters passim). Clarinex is a single-isomer variation on S-P's Claritin (loratadine), a $3 billion-a-year drug which is due to lose its US patent protection next year. The company hoped to launch the new version this year to defend its franchise as the Claritin expiry looms, but the FDA has said it will not give the drug final approval until S-P resolves manufacturing problems (Marketletter February 26).