United Therapeutics Announces Approval of Remodulin in France

United Therapeutics has announced that AFSSAPS, the French drug regulatory agency, has issued an approval letter for Remodulin injection for subcutaneous treatment of NYHA Class III primary pulmonary hypertension patients.

The approval letter did not request any additional clinical trials of subcutaneous Remodulin (treprostinil sodium). AFSSAPS has indicated that the mutual recognition approval process with other countries in the European Union will be initiated in May 2005.