[{"orgOrder":0,"company":"KYE Pharmaceuticals","sponsor":"Catalyst Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Catalyst Pharmaceuticals and KYE Pharmaceuticals Announce Agreement to Make Firdapse\u00ae Available to LEMS Patients in Canada","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"August 2020","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\u2019 Firdapse\u00ae (amifampridine phosphate) Receives Marketing Approval in Canada for Patients with LEMS","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","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 Announces Notice of Allowance of a U.S. Patent Application for \"Methods of Administering 3,4-Diaminopyridine\"","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"MEDUNIK CANADA","sponsor":"Jacobus Pharmaceutical Company, Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"M\u00e9dunik Canada's Ruzurgi\u00ae Now Available to Canadian Lambert-Eaton Myasthenic Syndrome Patients","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"KYE Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KYE Pharmaceuticals Announces Commercial Availability of FIRDAPSE in Canada","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"DyDo Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Catalyst Announces Exclusive License and Supply Agreement with DyDo Pharma for the Development and 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Find Clinical Drug Pipeline Developments & Deals for Amifampridine Phosphate
Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.
Firdapse (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome and FDA recently accepted to review the Company's sNDA to increase the indicated maximum daily dosage of amifampridine tablets 10 mg from 80mg to 100mg.
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).
A favorable decision from the Federal Court of Canada setting aside second time decision of Canada’s national healthcare regulatory agency, Health Canada, to approve Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome ("LEMS") patients.
FIRDAPSE® (amifampridine phosphate) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium channel blocker that causes depolarization of presynaptic membrane and slows or inhibits repolarization for treatment of adults with Lambert-Eaton myasthenic syndrome.
U.S. FDA approval of Ruzurgi® (Jacobus Pharmaceutical Company's amifampridine product) for the treatment of pediatric patients with Lambert-Eaton myasthenic syndrome ("LEMS") violated Catalyst's exclusivity for FIRDAPSE® (amifampridine) Tablets 10 mg under the Orphan Drug Act.
Firdapse® (amifampridine) Tablets 10 mg for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse® is commercially available in the United States as a treatment for adults with LEMS.
DyDo Pharma will have joint rights to develop Firdapse® (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan. Firdapse® is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that slows or inhibits repolarization.
KYE Pharmaceuticals announces FIRDAPSE® (amifampridine phosphate), the first amifampridine product approved in Canada, is now widely available for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
Médunik Canada has retained the services of Innomar, a leading specialty pharmaceutical service and patient support program provider, for the distribution of Ruzurgi® and management of its UnikAccess Patient Support Program.
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