Elan/Amarin Zelapar NDA accepted
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA accepts Elan's NDA filing for Zelapar, a fast-dissolving tablet formulation of the MAO-B inhibitor selegiline. Generically available selegiline is approved as adjunct treatment to levodopa for the symptoms of Parkinson's disease. The fast-dissolving formulation is intended to address the difficulty in swallowing Parkinson's patients may experience. Amarin has an option for U.S. right