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              Astellas Pharma

              • Development Update

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              FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and sNDA for Myrbetriq Tablets

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              Lead Product(s): Mirabegron

              Therapeutic Area: Urology Product Name: Myrbetriq

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 06, 2021

              Details:

              The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.

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