Ambrisentan tablets
Form: Tablets
Strength: 5 mg and 10 mg
Reference Brands: Letairis®(US & EU); Volibris®(EU)
Category: Orphan Drugs
Ambrisentan tablets, marketed as Letairis® and Volibris®, are approved in the US and EU for pulmonary arterial hypertension (PAH). Regulatory dossiers include comprehensive clinical trial data, manufacturing standards, and safety profiles, supporting approval by the FDA and EMA. These dossiers demonstrate Ambrisentan’s efficacy in improving exercise capacity and reducing PAH symptoms. Available in 5 mg and 10 mg tablets, dosing can be tailored to patient response. For detailed insights on regulatory processes, dossier submissions, and market approvals in the EU and US, 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.
Related Products
Galsulfase IV
Strength: 1mg/ml
Form: Lyophilized powder for IV
Reference Brands: Vimizim®(US & EU)
View Details Get Enquiry
Alglucosidase Alfa IV
Strength: 50 mg/vial
Form: Lyophilized powder
Reference Brands: Lumizyme®(US & EU)
View Details Get Enquiry
Nitisinone tablets
Strength: 2 mg and 5 mg
Form: Tablets
Reference Brands: Orfadin®
View Details Get Enquiry
Treprostinil IV or SC
Strength: 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL)
Form: SC or Intravenous (IV)
Reference Brands: Remodulin®(US & EU)
View Details Get Enquiry