Bosentan tablet
Form: Tablets
Strength: 62.5 mg and 125 mg
Reference Brands: Tracleer®(US & EU)
Category: Orphan Drugs
Bosentan tablets, marketed as Tracleer®, are approved in the US and EU for pulmonary arterial hypertension. Regulatory dossiers include extensive clinical trials, manufacturing compliance, and safety data, facilitating approval by FDA and EMA. These dossiers highlight bosentan’s efficacy in improving exercise capacity and reducing symptoms of PAH. The medication is available in 62.5 mg and 125 mg tablets, with dosing titrated based on patient response. For detailed insights on regulatory submissions, dossier requirements, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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