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Details for New Drug Application (NDA): 208078
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NDA 208078 describes FIRDAPSE, which is a drug marketed by Catalyst Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the FIRDAPSE profile page.
The generic ingredient in FIRDAPSE is amifampridine phosphate. One supplier is listed for this compound. Additional details are available on the amifampridine phosphate profile page.
The generic ingredient in FIRDAPSE is amifampridine phosphate. One supplier is listed for this compound. Additional details are available on the amifampridine phosphate profile page.
Summary for 208078
| Tradename: | FIRDAPSE |
| Applicant: | Catalyst Pharms |
| Ingredient: | amifampridine phosphate |
| Patents: | 0 |
Generic Entry Opportunity Date for 208078
Generic Entry Date for 208078*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN ADULTS Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 208078
| Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 208078
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078 | NDA | Catalyst Pharmaceuticals, Inc. | 69616-211 | 69616-211-03 | 240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03) |
| FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078 | NDA | Catalyst Pharmaceuticals, Inc. | 69616-211 | 69616-211-06 | 12 BLISTER PACK in 1 CARTON (69616-211-06) > 10 TABLET in 1 BLISTER PACK (69616-211-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Nov 28, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN ADULTS | ||||||||
| Regulatory Exclusivity Expiration: | Nov 28, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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