United Therapeutics Corporation (NASDAQ:UTHR, www.unither.com), has received an approval letter from the FDA for the intravenous dosing of Remodulin, the company's treatment for pulmonary arterial hypertension. United Therapeutics, which has its headquarters in Maryland and R&D operations in the RTP, had filed a supplemental NDA 10 months ago. With the FDA's approval, Remodulin is now available for commercial intravenous use.
The FDA approval letter did not request additional clinical trials of intravenous Remodulin, but the company will conduct a Phase 4 post marketing trial as part of the FDA's accelerated approval regulations. United Therapeutics is a biotechnology company focused on combating chronic and life-threatening cardiovascular, vascular and oncological diseases.