[{"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"}]
Find Clinical Drug Pipeline Developments & Deals for Amifampridine
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").
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").
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).