ALPMF - FDA grants two priority reviews to Astellas' bladder control treatment

Astellas Pharma (ALPMF) announces that the FDA has granted priority reviews for marketing application seeking approval for mirabegron for oral suspension and supplemental application for Myrbetriq (mirabegron) tablets for neurogenic detrusor overactivity ((NDO)) in pediatric patients aged three years and older.Agency's action date is set at March 28.NDO is bladder dysfunction frequently observed in patients with conditions such as multiple sclerosis and spinal cord injury.Myrbetriq tablets were initially approved in 2012 in the U.S. for the treatment of adults with overactive bladder.

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FDA grants two priority reviews to Astellas' bladder control treatment