Gatifloxacin eye drops

Form: Ophthalmic Drops

Strength: 0.5%

Reference Brands: Zymaxid (US), Zymar (EU)

Category: Antibiotics

Gatifloxacin eye drops are approved in the EU and US for treating bacterial conjunctivitis and keratitis. In the EU, brands like Zymar are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data, with generic formulations available. Both regions require detailed dossiers, including clinical trial results, manufacturing practices, and pharmacovigilance plans for approval and safety monitoring. Due to their widespread use, strict regulations on labeling, dosing, and usage are enforced to ensure safety and effectiveness. For expert support with regulatory dossiers and registration, visit PharmaTradz. We support seamless market access adhering to European and US standards for safe, effective ocular therapy.