Overview
Dalfampridine is a potassium channel blocker used to help multiple sclerosis patients walk. This is the first drug that was specifically approved to help with mobility in these patients. FDA approved on January 22, 2010.
Indication
Dalfampridine is a neurofunctional modifier that helps improve walking speed in patients with multiple sclerosis (MS).
Associated Conditions
- Multiple Sclerosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/25 | Phase 1 | Recruiting | |||
2024/12/30 | Phase 2 | Recruiting | |||
2024/09/19 | Phase 2 | Not yet recruiting | John Elfar | ||
2024/03/27 | Phase 2 | Recruiting | John Elfar | ||
2024/03/06 | Phase 2 | Not yet recruiting | John Elfar | ||
2023/11/18 | Phase 4 | Recruiting | MGH Institute of Health Professions | ||
2023/08/21 | Phase 2 | Recruiting | |||
2023/05/16 | Phase 2 | Completed | |||
2023/02/16 | Not Applicable | Recruiting | |||
2022/11/14 | Not Applicable | Completed | European University of Lefke |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Golden State Medical Supply, Inc. | 51407-246 | ORAL | 10 mg in 1 1 | 2/21/2024 | |
| Aurobindo Pharma Limited | 65862-863 | ORAL | 10 mg in 1 1 | 2/15/2024 | |
| Actavis Pharma, Inc. | 0591-2533 | ORAL | 10 mg in 1 1 | 12/2/2021 | |
| Golden State Medical Supply, Inc. | 51407-876 | ORAL | 10 mg in 1 1 | 2/12/2024 | |
| Acorda Therapeutics, Inc. | 10144-427 | ORAL | 10 mg in 1 1 | 3/12/2024 | |
| Sun Pharmaceutical Industries, Inc. | 62756-429 | ORAL | 10 mg in 1 1 | 10/16/2023 | |
| Accord Healthcare Inc. | 16729-292 | ORAL | 10 mg in 1 1 | 1/4/2024 | |
| Ascend Laboratories, LLC | 67877-444 | ORAL | 10 mg in 1 1 | 6/30/2022 | |
| Micro Labs Limited | 42571-275 | ORAL | 10 mg in 1 1 | 11/28/2022 | |
| Bryant Ranch Prepack | 63629-9450 | ORAL | 10 mg in 1 1 | 11/18/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/24/2020 | ||
Authorised | 9/24/2020 | ||
Authorised | 7/20/2011 | ||
Authorised | 7/20/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FAMPYRA fampridine 10mg modified release tablets bottle | 170002 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 5/24/2011 |
| FAMPRIDINE MR APOTEX fampridine 10mg modified release tablets blister pack | 278732 | Medicine | A | 8/25/2017 | |
| APO-FAMPRIDINE MR fampridine 10mg modified release tablets blister pack | 278731 | Medicine | A | 8/25/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PMS-FAMPRIDINE | 02496216 | Tablet (Extended-Release) - Oral | 10 MG | 4/12/2021 | |
| TARO-FAMPRIDINE | 02482398 | Tablet (Extended-Release) - Oral | 10 MG | 11/24/2020 | |
| APO-FAMPRIDINE | 02491672 | Tablet (Extended-Release) - Oral | 10 MG | N/A | |
| FAMPYRA | 02379910 | Tablet (Extended-Release) - Oral | 10 MG | 2/24/2012 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FAMPRIDINA TEVA 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Teva Pharma S.L.U. | 86366 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized |
| FAMPYRA 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA | 11699003 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Commercialized | |
| FAMPRIDINA DESITIN 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | 85562 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized | |
| FAMPRIDINA STADA 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Laboratorio Stada S.L. | 87323 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized |
| FAMPRIDINA SUN 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | 85992 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized | |
| FAMPRIDINA QUALIGEN 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Neuraxpharm Spain S.L. | 86057 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized |
| FAMPRIDINA SANDOZ 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Sandoz Farmaceutica S.A. | 87978 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized |
| FAMPRIDINA AUROVITAS 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Aurovitas Spain, S.A.U. | 87979 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized |
| FAMPRIDINA ACCORD 10 mg COMPRIMIDOS DE LIBERACION PROLONGADA EFG | 1201477001 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Not Commercialized | |
| FAMPYRA 10 MG COMPRIMIDOS DE LIBERACION PROLONGADA | 11699004 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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