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FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Susp...

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.