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FDA Accepts Supplemental NDA For Intravenous Remodulin
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., March 31 /PRNewswire-FirstCall/ -- United Therapeutics Corporation announced today that its intravenous Remodulin supplemental New Drug Application (sNDA) has been accepted for review by the United States Food and Drug Administration (FDA). The sNDA was submitted on January 30, 2004 to add the intravenous route of delivery to the Remodulin label for the treatment of patients with pulmonary arterial hypertension. The FDA has until November 30, 2004 to issue an action letter for the sNDA.
"We are pleased to see that our accelerated efforts to bring broader treatment options to the pulmonary hypertension community have satisfied the threshold standards at the FDA," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer.
Source: United Therapeutics Corporation