FDA approves first treatment for Lambert-Eaton myasthenic syndrome…
The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder...
FDA Approves Dose Expansion of Catalyst's Amifampridine for …
Jun 3, 2024 · The FDA has approved a supplemental new drug application (sNDA) for a higher maximum daily dose of Catalyst Pharmaceuticals’ potassium channel blocker amifampridine (Firdapse) for the treatment of adults and pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune neuromuscular disorder characterized primarily by muscl...
FDA approves increased amifampridine maximum daily dose to …
Jun 3, 2024 · With the federal agency's decision, the maximum daily dose increased from 80 mg to 100 mg, for adults and pediatric patients who weigh more than 45 kg, allowing for greater flexibility in treatment regimens for the management of LEMS.
First Treatment for Rare Autoimmune Disorder Receives FDA Approval
Nov 29, 2018 · Officials with the FDA have approved amifampridine (Firdapse, Catalyst Pharmaceuticals) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder, according to a press release. 1
FDA approves first treatment for children with Lambert-Eaton …
The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This...
Amifampridine - Wikipedia
In May 2019, the US Food and Drug Administration (FDA) approved amifampridine tablets under the brand name Ruzurgi for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in people 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS.
News & Events | FIRDAPSE® (amifampridine) - HCP
On May 30, 2024, Catalyst Pharmaceuticals, Inc. received approval by the U.S. Food and Drug Administration (FDA) increasing the indicated maximum daily dose of FIRDAPSE (amifampridine) for adults from 80 mg to 100 mg for the treatment of …
Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE ...
Jan 8, 2025 · This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of FIRDAPSE ® (amifampridine) 10 mg tablets prior to …
Firdapse (amifampridine) for LEMS - Lambert-Eaton News
Oct 1, 2024 · Firdapse (amifampridine) is an oral therapy for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). It works to improve muscle strength and mobility in adults and children with the autoimmune disease.
Catalyst's FIRDAPSE Approved For Use In Japan, Offering New
4 days ago · (RTTNews) - Catalyst Pharmaceuticals, Inc. (CPRX), a commercial-stage biopharmaceutical company, Tuesday announced that its sub-licensee, DyDo Pharma, has launched FIRDAPSE or amifampridine ...
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