Ponesimod tablets:

Form: Tablet

Strength: 20 mg

Reference Brands: Gilyea(US & EU)

Category: Multiple sclerosis

Ponesimod, marketed as Gilyea, is approved in the US by the FDA and in the EU via EMA for relapsing multiple sclerosis (MS). Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, FDA review involves comprehensive analysis of clinical trial results and manufacturing standards, while the EMA ensures compliance with regional safety and quality regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance is crucial for the timely approval, safe use, and global availability of ponesimod tablets, supporting effective MS management worldwide.