Mesalamine (5-ASA) tablets

Form: Tablets

Strength: 400 mg, 500 mg, and 1 g

Reference Brands: Asacol HD, Lialda, Pentasa(US)

Category: Gastrointestinal Drugs

Mesalamine (5-ASA) tablets and capsules, marketed as Asacol, Pentasa, and Lialda, are approved in the US by the FDA and in the EU via EMA for ulcerative colitis and Crohn’s disease. Approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data for prompt approval, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional compliance supports timely approval, safe use, and worldwide availability, helping improve patient outcomes for inflammatory bowel diseases globally.