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[{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for FIRDAPSE\u00ae Expanding Patient Population to Include Pediatric Patients","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Advances sNDA Submission Plans To Increase Indicated Maximum Dose For FIRDAPSE\u00ae From 80 mg Per Day To 100 mg Per Day","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"DyDo Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Catalyst Pharmaceuticals Announces DyDo Pharma Initiation of a Phase 3 Study for FIRDAPSE\u00ae (amifampridine) in Japan","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"}]

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            Details:

            Firdapse (amifampridine) is a broad spectrum potassium channel blocker. sNDA submission has been planned to increase indicated maximum dose for firdapse® from 80 mg per day to 100 mg per day for the treatment of lambert eaton myasthenic syndrome ("LEMS").

            Lead Product(s): Amifampridine

            Therapeutic Area: Immunology Product Name: Firdapse

            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 May 09, 2023

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            Details:

            Supplemental New Drug Application ("sNDA") to expand the indicated age range for FIRDAPSE® (amifampridine) Tablets 10 mg to include pediatric patients, six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").

            Lead Product(s): Amifampridine

            Therapeutic Area: Immunology Product Name: Firdapse

            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 September 29, 2022

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            Details:

            Firdapse (amifampridine phosphate) is a broad spectrum potassium channel blocker. Amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

            Lead Product(s): Amifampridine

            Therapeutic Area: Immunology Product Name: Firdapse

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: DyDo Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 06, 2021

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