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Details:
Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.
Lead Product(s): Solifenacin Succinate,Mirabegron
Therapeutic Area: Urology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
The U.S. Food and Drug Administration (FDA) approved Myrbetriq for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules for the treatment of NDO in pediatric patients aged three years and older.
Lead Product(s): Mirabegron
Therapeutic Area: Urology Product Name: Myrbetriq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 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.
Lead Product(s): Mirabegron
Therapeutic Area: Urology Product Name: Myrbetriq
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
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