Zolmitriptan oral dispersible film regulatory update

Germany's regulatory agency accepted for review an MAA from Applied Pharma 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 and tesa's Labtec GmbH subsidiary co-developed the oral film strip formulation of the serotonin (5-HT1B) and 5-HT1D receptor agonist (see BioCentury, June 14). ...