Treprostinil IV or SC

Form: SC or Intravenous (IV)

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)

Reference Brands: Remodulin®(US & EU)

Category: Orphan Drugs

Treprostinil, marketed as Remodulin®, is approved in the US and EU for pulmonary arterial hypertension (PAH). Regulatory dossiers include comprehensive clinical data, manufacturing standards, and safety profiles submitted to FDA and EMA, supporting its approval for subcutaneous and intravenous use. The product is used for continuous infusion to improve exercise capacity and reduce symptoms. Dossiers demonstrate high-quality manufacturing and proven efficacy. For detailed insights on regulatory submissions, dossier requirements, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry insights.