This section highlights FDA-related milestones and regulatory updates for drugs developed by Catalyst Pharmaceuticals (CPRX).
Over the past two years, Catalyst Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AGAMREE® and FIRDAPSE®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AGAMREE® (vamorolone) FDA Regulatory Events
AGAMREE® (vamorolone) is a drug developed by Catalyst Pharmaceuticals for the following indication: For The Treatment Of Duchenne Muscular Dystrophy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AGAMREE® (vamorolone)
- Announced Date:
- April 8, 2025
- Indication:
- For The Treatment Of Duchenne Muscular Dystrophy
Announcement
Catalyst Pharmaceuticals, Inc today reported that its sub-licensee in Canada, Kye Pharmaceuticals, Inc. (Kye), has announced that Health Canada has accepted the New Drug Submission (NDS) for AGAMREE®, a novel corticosteroid treatment for Duchenne muscular dystrophy (DMD), for review.
AI Summary
Catalyst Pharmaceuticals announced that its Canadian sub-licensee, Kye Pharmaceuticals, has informed the company that Health Canada has accepted the New Drug Submission (NDS) for AGAMREE®. This submission, which will undergo a Priority Review, speeds up the regulatory process and could lead to marketing authorization by the end of 2025. If approved, AGAMREE® will be the first treatment option specifically indicated for patients with Duchenne muscular dystrophy (DMD) in Canada. DMD is a serious genetic disorder that causes progressive muscle degeneration, particularly affecting young boys. The acceptance of the submission by Health Canada highlights the potential of AGAMREE® as an innovative corticosteroid treatment that could address a significant unmet need for Canadian patients with DMD. Catalyst, along with Kye Pharmaceuticals, is committed to bringing this novel therapy to market to improve patient outcomes and expand access to effective treatments.
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FIRDAPSE® FDA Regulatory Timeline and Events
FIRDAPSE® is a drug developed by Catalyst Pharmaceuticals for the following indication: For the treatment of LEMS.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FIRDAPSE®
- Announced Date:
- August 25, 2025
- Indication:
- For the treatment of LEMS
Announcement
Catalyst Pharmaceuticals, Inc. announced that the Company and its licensor SERB S.A. ("SERB") have entered into a Settlement Agreement ("Agreement") with Lupin Ltd and Lupin Pharmaceuticals, Inc. (collectively, "Lupin").
AI Summary
On August 25, 2025, Catalyst Pharmaceuticals, Inc. and its licensor SERB S.A. announced a settlement with Lupin Ltd and Lupin Pharmaceuticals, Inc. This agreement ends the patent lawsuit over Lupin’s ANDA application for a generic version of FIRDAPSE® (amifampridine) 10 mg tablets.
Under the agreement, if the FDA approves Lupin’s generic, the company must wait until February 25, 2035, to launch in the U.S., unless certain limited, customary conditions are met.
All current patent cases between Catalyst/SERB and Lupin in the U.S. District Court for the District of New Jersey will be dismissed. The confidential settlement will be submitted to the U.S. Federal Trade Commission and Department of Justice for review.
This deal secures FIRDAPSE’s patent protection and provides clarity for patients relying on this medicine for rare neuromuscular disease.
Read Announcement- Drug:
- FIRDAPSE®
- Announced Date:
- January 21, 2025
- Indication:
- For the treatment of LEMS
Announcement
Catalyst Pharmaceuticals, Inc. today reported that its sub-licensee in Japan, DyDo Pharma, Inc., ("DyDo") has launched FIRDAPSE® (amifampridine) Tablets 10 mg in Japan for the indication of improving muscle weakness in patients living with Lambert-Eaton myasthenic syndrome ("LEMS").
AI Summary
Catalyst Pharmaceuticals announced that its sub-licensee in Japan, DyDo Pharma, Inc., has launched FIRDAPSE® (amifampridine) Tablets 10 mg in Japan. The medication is designed to improve muscle weakness in patients with Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that causes muscle weakness and fatigue. According to Catalyst, this launch marks an important step in expanding patient access to life-changing therapies internationally. FIRDAPSE is known as the only evidence-based treatment approved by the U.S. FDA for both adults and pediatric patients aged six years and older who suffer from LEMS. With this development, healthcare providers and patients in Japan will have access to a critical medicine that can help manage the symptoms of the condition, furthering Catalyst’s commitment to health equity and increased global accessibility to treatments for rare diseases.
Read Announcement- Drug:
- FIRDAPSE®
- Announced Date:
- May 30, 2024
- Indication:
- For the treatment of LEMS
Announcement
Catalyst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") has approved its 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").
AI Summary
Catalyst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) that increases the maximum daily dose of FIRDAPSE® (amifampridine) from 80 mg to 100 mg. This update applies to adults and pediatric patients weighing more than 45 kg who are being treated for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that causes muscle weakness and fatigue.
The increased dosage provides healthcare providers with more flexibility in designing treatment regimens for managing LEMS, potentially improving patient outcomes. FIRDAPSE is currently recognized as the only U.S. approved treatment for LEMS and works by enhancing the release of acetylcholine at the neuromuscular junction, which in turn improves muscle function. Catalyst’s announcement underscores its commitment to addressing the evolving needs of LEMS patients and their healthcare teams.
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