Active substance
Dalfampridine
- SFDA 1
- US FDA 9
- US price lines 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PEMAR 10 mg prolonged-release tablet | 10 mg | Prolonged-release tablet · Oral use | 60 Blister | SAR 1731.00 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
Indications — CHI Daman Drug Formulary
MULTIPLE SCLEROSIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AMPYRA | 10MG | tablet, extended release · oral | MERZ | Prescription | 22 Jan 2010 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | AUROBINDO PHARMA | Prescription | 23 Jan 2017 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | ACTAVIS LABS FL INC | Prescription | 23 Jan 2017 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | ACCORD HLTHCARE | Prescription | 11 Jul 2018 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | ALKEM LABS LTD | Prescription | 30 Jul 2018 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | MICRO LABS | Prescription | 11 Mar 2019 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | HIKMA PHARMS | Discontinued | 24 Oct 2018 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | SUN PHARM | Discontinued | 21 May 2019 |
| DALFAMPRIDINE | 10MG | tablet, extended release · oral | RISING | Discontinued | 6 Jul 2020 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DALFAMPRIDINE ER 10 MG TABLET | $0.39924 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 18 Nov 2021 AMPYRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.