Desloratadine cleared in European Union

The European Medicines Evaluation Agency has granted marketing approvalto Schering-Plough for Aerius/Neoclarityn (desloratadine), a single-isomer follow-up to its blockbuster Claritin (loratadine) which achieved sales of $2.7 billion in 1999 but faces US patent expiration at the end of next year. This is the first marketing approval for the new drug, which has not yet been approved in the USA despite being under review at the Food and Drug Administration for over a year (Marketletter November 6, 2000).

The 5mg tablet formulation of desloratadine has been approved as a once-daily, nonsedating treatment for seasonal allergic rhinitis in adults and children 12 years of age and older. S-P said that the product will be introduced "swiftly" in the European Union after receiving pricing and/or reimbursement approvals, where necessary. S-P licenses the product from Sepracor.

Superior to Claritin?