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    [{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and sNDA for Myrbetriq Tablets","therapeuticArea":"Urology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Urology","graph2":"Phase III"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Urology","graph2":"Approved"},{"orgOrder":0,"company":"MSN Laboratories","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MSN Laboratories Gets CDSCO Panel Nod For FDCs Solifenacin, Mirabegron Capsules","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Urology","graph2":"Approved"}]

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              MSN Laboratories

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              MSN Laboratories Gets CDSCO Panel Nod For FDCs Solifenacin, Mirabegron Capsules

              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: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 30, 2022

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              Astellas Pharma

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              Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)

              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: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 26, 2021

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              Astellas Pharma

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

              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 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

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