2021-01-06 08:04:33 ALPMY Astellas Pharma
01/06/21 01/0608:04 01/06/2108:04 | Astellas Pharma: FDA accepts for Priority Review NDA for mirabegronAstellas Pharma announced that the U.S. FDA accepted priority review for its New Drug Application for mirabegron for oral suspension and its supplemental New Drug Application for Myrbetriq tablets for the treatment of neurogenic detrusor overactivity in pediatric patients aged three years and older. The Prescription Drug User Fee Act goal date for a decision by the FDA is March 28, 2021. |
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