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    [{"orgOrder":0,"company":"Adlon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Supplemental New Drug Application for Adhansia XR\u00ae (methylphenidate HCl) Extended-Release Capsules CII","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"}]

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              FDA Approves Supplemental New Drug Application for Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII

              Details:

              The sNDA approval was based on data from a randomized, double-blind, parallel-group, placebo-controlled, Phase 3 Adult Laboratory Classroom (ALC) study evaluating the safety and efficacy of Adhansia XR in adult patients diagnosed with ADHD.

              Lead Product(s): Methylphenidate Hydrochloride

              Therapeutic Area: Psychiatry/Psychology Product Name: Adhansia XR

              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 July 01, 2021

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