Search Orphan Drug Designations and Approvals
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| Generic Name: | amifampridine | ||||||||||||||||
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| Trade Name: | Firdapse | ||||||||||||||||
| Date Designated: | 11/12/2009 | ||||||||||||||||
| Orphan Designation: | Treatment of Lambert-Eaton Myasthenic Syndrome | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Catalyst Pharmaceuticals, Inc. 355 Alhambra Circle Suite 1250 Coral Gables, Florida 33134 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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| 1 | Generic Name: | amifampridine |
|---|---|---|
| Trade Name: | Firdapse | |
| Marketing Approval Date: | 11/28/2018 | |
| Approved Labeled Indication: | Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults | |
| Exclusivity End Date: | 11/28/2025 | |
| Exclusivity Protected Indication* : | Treatment of Lambert-Eaton myasthenic syndrome (LEMS) | |
| 2 | Generic Name: | amifampridine |
|---|---|---|
| Trade Name: | Firdapse | |
| Marketing Approval Date: | 09/29/2022 | |
| Approved Labeled Indication: | Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older | |
| Exclusivity End Date: | TBD | |
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