EU approval is given for intravenous formulation of Remodulin (United Therapeutics) - 29-Dec-2011

European approval has been given to United Therapeutics Corp for the intravenous formulation of its prostacyclin vasodilator, Remodulin (treprostinil), to treat Pulmonary Arterial Hypertension (PAH). Twenty two European Union member states have approved the formulation through the French regulatory agency AFSSAPS under the mutual recognition process. United Therapeutics has separately filed in the US for the oral version of Remodulin. The product is already approved in most of Europe via subcutaneous administration, and intravenous infusion should be reserved for those who are intolerant of subcutaneous infusion, because of the risks associated with chronic indwelling intravenous catheters, including serious blood stream infections