The therapeutic window for FIRDAPSE has expanded! https://lnkd.in/gx-T9U_5 IMPORTANT SAFETY INFORMATION: INDICATIONS AND USAGE: FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. CONTRAINDICATIONS FIRDAPSE is contraindicated in patients with: • A history of seizures • Hypersensitivity to amifampridine phosphate or another aminopyridine WARNINGS AND PRECAUTIONS Seizures: FIRDAPSE can cause seizures. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. Hypersensitivity: If a hypersensitivity reaction such as anaphylaxis occurs, FIRDAPSE should be discontinued and appropriate therapy initiated. ADVERSE REACTIONS The most common (> 10%) adverse reactions are: paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms. Please see full Prescribing Information: https://lnkd.in/gudBQ5wU for additional Important Safety Information. To report SUSPECTED ADVERSE REACTIONS, contact Catalyst Pharmaceuticals at 1-844-347-3277 (1-844-FIRDAPSE) or FDA at 1-800-FDA-1088 or https://lnkd.in/gcQWcr-3.
Catalyst Pharmaceuticals, Inc.
Pharmaceutical Manufacturing
Coral Gables, Florida 10,518 followers
We are focused on developing and commercializing innovative therapies for people with rare neurological diseases.
About us
About Catalyst Pharmaceuticals, Inc. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("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 and children ages six to seventeen with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.
- Website
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http://www.catalystpharma.com
External link for Catalyst Pharmaceuticals, Inc.
- Industry
- Pharmaceutical Manufacturing
- Company size
- 51-200 employees
- Headquarters
- Coral Gables, Florida
- Type
- Public Company
- Founded
- 2002
- Specialties
- Neurology, Neuromuscular, Pharmaceuticals, and Rare Disease
Locations
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Primary
355 Alhambra Circle
Suite 801
Coral Gables, Florida 33134, US
Employees at Catalyst Pharmaceuticals, Inc.
Updates
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Catalyst Pharmaceuticals, Inc. is pleased to provide the Company’s 2023 Environmental, Social, and Governance (ESG) Report. The ESG Report outlines our practices, policies, and performance on relevant ESG issues during the fiscal year. Learn more: https://lnkd.in/gx9D49fK
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Team Catalyst is enjoying connecting with the DMD Community at Parent Project Muscular Dystrophy’s 30th Annual Conference. Over a thousand attendees- made up of families, researchers, clinicians, and industry partners- have come together to share information and engage in sessions covering the latest news in research, clinical trials, approved and emerging therapies, care initiatives, quality of life issues, and more. Visit our booth to learn how Catalyst is serving the DMD Community. #PPMD2024
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June is #MyastheniaGravis (MG) awareness month. As MG can be misdiagnosed with Lambert-Eaton myasthenic syndrome (LEMS), take a moment to learn more about the clinical overlap between MG and #LEMS to potentially shorten a patient's diagnostic journey: https://lnkd.in/gA9fdhtZ
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Many people with LEMS struggle with symptoms for years before finally getting diagnosed. It is important to see a physician who has experience with diagnosing neuromuscular diseases. An early, accurate diagnosis can be beneficial for your health. Find out how: https://lnkd.in/gh_-r_s6 IMPORTANT SAFETY INFORMATION: INDICATIONS AND USAGE: FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. CONTRAINDICATIONS FIRDAPSE is contraindicated in patients with: • A history of seizures • Hypersensitivity to amifampridine phosphate or another aminopyridine WARNINGS AND PRECAUTIONS Seizures: FIRDAPSE can cause seizures. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. Hypersensitivity: If a hypersensitivity reaction such as anaphylaxis occurs, FIRDAPSE should be discontinued and appropriate therapy initiated. ADVERSE REACTIONS The most common (> 10%) adverse reactions are: paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms. Please see full Prescribing Information: https://lnkd.in/gqN8Rund for additional Important Safety Information. To report SUSPECTED ADVERSE REACTIONS, contact Catalyst Pharmaceuticals at 1-844-347-3277 (1-844-FIRDAPSE) or FDA at 1-800-FDA-1088 or https://lnkd.in/gcQWcr-3.
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June is #MyastheniaGravis (MG) awareness month. More than 1/3 of diagnosed Lambert-Eaton myasthenic syndrome (LEMS) patients were previously diagnosed as having MG. Studies reveal that more than half of patients with LEMS received a different diagnosis first. Learn more about MG and LEMS commonalities: https://lnkd.in/gDWH3FnD
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Attending Biotechnology Innovation Organization's #BIO2024 Convention? Look out for Team Catalyst at tonight’s Welcome Reception. Our Advocacy, Strategy, and Business Development teams would love to connect on all things #raredisease. See you there. Check out BIO's one-on-one partnering page to connect with Catalyst's Preethi Sundaram, Stanley Iyadurai PhD MD, Jennifer Isler OCain, PhD, and more this week.
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The U.S. Food and Drug Administration has approved Catalyst Pharmaceuticals, Inc.’s supplemental New Drug Application (“sNDA”) increasing the indicated maximum daily dose of FIRDAPSE® (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”). The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for managing LEMS. Learn more below.
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