Baclofen Tablets:

Form: Tablet

Strength: 10 mg and 20 mg

Reference Brands: Lioresal, Gablofen(US & EU)

Category: Multiple sclerosis

Baclofen tablets, marketed as Lioresal, are approved in the US by the FDA and in the EU via EMA for treating spasticity in multiple sclerosis, spinal cord injury, and other neurological conditions. 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 and manufacturing information, 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 regulatory compliance is crucial for timely approval, safe use, and global availability of Baclofen tablets, supporting optimal patient management worldwide.