Germany reviewing oral film formulation of zolmitriptan

Germany's regulatory agency accepted for review an MAA from Applied Pharma Research S.A. (Balerna, Switzerland) for zolmitriptan oral dispersible film to treat migraine. The application was submitted under the EU's decentralized procedure, with Germany acting as the reference member state. Applied Pharma expects the review to be completed by 2Q12. Applied Pharma, MonoSol Rx LLC (Warren, N.J.) and Labtec GmbH (Langenfeld, Germany) co-developed the oral film strip formulation of the serotonin (5-HT1B) and 5-HT1D receptor agonist. ...