Tetrabenazine tablets
Form: Tablets
Strength: 25 mg, 50 mg, 75 mg
Reference Brands: Xenazine(US)
Category: Orphan Drugs
Tetrabenazine tablets, marketed as Xenazine, are approved in the US by the FDA and in the EU via EMA for treating hyperkinetic movement disorders such as Huntington’s disease chorea. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data to ensure safety and efficacy, while the EMA ensures regional compliance with safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports timely approval, safe use, and worldwide availability, helping improve quality of life for patients with movement disorders.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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