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news.The French regulatory agency, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), has approved United Therapeutics’ intravenous use of Remodulin (treprostinil) for the treatment of pulmonary arterial hypertension (PAH)
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Remodulin is approved for the continuous subcutaneous infusion treatment of idiopathic or heritable PAH to improve exercise tolerance and symptoms of the disease.
For intravenous Remodulin, United Therapeutics will implement an RMP focused on minimizing the known risks of central venous catheter-related blood stream infections associated with intravenous administration, the company said.
The company also submitted a new drug application (NDA) to FDA for treprostinil diethanolamine sustained release tablets (oral treprostinil) for the treatment of PAH.
United Therapeutics president and chief operating officer Roger Jeffs said the approval significantly expands the treatment options for PAH patients using parenteral therapy in Europe.