Astellas Pharma Inc. (Tokyo: 4503, “Astellas”) today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) indicating that it accepted for filing the New Drug Application for mirabegron (generic name / code name: YM178) and initiated a substantive review. The target date for the review completion (PDUFA date) is June 29, 2012. A similar letter from the European Medicines Agency (EMA) validating the application and confirming the start of the review procedure was received.
