Dalfampridine

Form: Extended-Release tablets (XR)

Strength: 10 mg

Reference Brands: Ampyra(US)

Category: Multiple sclerosis

Dalfampridine extended-release (ER) tablets, marketed as Ampyra, are approved in the US by the FDA and in the EU via EMA for improving walking in multiple sclerosis (MS) patients. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial results and manufacturing standards, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough compliance is essential for timely approval, safe use, and global availability, ultimately supporting MS patients’ mobility worldwide.