United Therapeutics Corp. (Nasdaq: UTHR) says its intravenous Remodulin supplemental New Drug Application (sNDA) has been accepted for review by the FDA.

The sNDA was submitted on Jan. 30 to add the intravenous route of delivery to the Remodulin label for the treatment of patients with pulmonary arterial hypertension.

The FDA has until Nov. 30 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, president and chief operating officer of United.

The Silver Spring, MD-based biotech company, which has its research and development facility in RTP, focuses on combating chronic and life-threatening cardiovascular, infectious and oncological diseases.

Shares of UTHR closed down 37 cents at $23.83 after reaching $24.60 in early morning trading on the Nasdaq. The stock is approaching its 52-week mark of $25.17, while the yearly low is $16.20.

United Therapeutics: www.unither.com