Acyclovir tablet

Form: Tablets

Strength: 200 mg, 400 mg, 800 mg

Reference Brands: Zovirax(US & EU)

Category: Transplant

Acyclovir tablets, marketed as Zovirax, are approved in the US by the FDA and in the EU via EMA for treating herpes simplex, varicella-zoster, and herpes zoster infections. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures regional compliance with safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and worldwide availability, enabling effective antiviral management for herpes and related infections.