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Astellas Awaiting Safety Data For Mirabegron; Expects To File NDA In U.S. In Q2

This article was originally published in PharmAsia News

Executive Summary

TOKYO - Astellas provided an update on development for blockbuster-hopeful mirabegron, and the main theme of its progress appears to be safety, or rather waiting for safety data. The company delayed U.S. and EU filings for the drug on regulatory requests for more safety data to assess cardiovascular risk. The company rescheduled mirabegron's FDA filing for 2Q/FY2011, and now everyone is waiting for full results on additional safety studies
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