Methyldopa tablets

Form: Tablets

Strength: 250 mg, 500 mg, and 750 mg

Reference Brands: Aldomet(US)

Category: Hypertension

Methyldopa tablets, marketed as Aldomet, are approved in the US by the FDA and in the EU via EMA for managing hypertension, particularly during pregnancy. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data to ensure safety and effectiveness, while EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Adhering to regional requirements supports timely approval, safe medication use, and global availability to help manage hypertension effectively worldwide.