Schering Claritin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Receives additional six-month marketing exclusivity for all formulations of the product based on pediatric studies. Loratadine's compound patent is set to expire in June 2002. The pediatric studies support two sNDAs for the syrup formulation of loratadine. The first was filed in November 1999 for treatment of seasonal allergic rhinitis in children two to five years old. The second sNDA, filed in June 2000, would add safety information to labeling for children six months to two years old. Claritin Syrup is currently indicated for use in children 6 and olde