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Sceptical US FDA panel gives nod for Astellas overactive bladder drug

This article was originally published in Scrip

Executive Summary

With a somewhat tone of scepticism, a panel of advisers to the US FDA on 5 April backed approval of Astellas Pharma's experimental overactive bladder (OAB) drug mirabegron, voting 7-4, with one abstention, that the investigational medicine's benefits outweighed its risks of elevated heart rate, blood pressure and liver toxicity.



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