Tyvaso

Inhaled Treprostinil New Drug Application Filed by FDA

SILVER SPRING, Md., September 03, 2008 /PRNewswire-FirstCall/ -- United Therapeutics Corporation and its wholly-owned subsidiary Lung Rx, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for inhaled treprostinil for the treatment of pulmonary arterial hypertension. The NDA will be subject to a standard review period of 10 months, with a targeted user fee deadline of April 30, 2009.

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer.

Lung Rx, Inc. is a biotechnology company focused on unmet medical needs in pulmonary medicine and pulmonary delivery of innovative therapeutic products. [uthr-g]

CONTACT: Andrew Fisher of United Therapeutics Corporation,+1-202-483-7000, Afisher@unither.com

Web site: http://www.unither.com/

Ticker Symbol: (NASDAQ-NMS:UTHR)

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Posted: September 2008

Related Articles

• FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension - July 30, 2009
• U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months - April 28, 2009
• United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso) - March 16, 2009
• New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration - June 30, 2008

Tyvaso (treprostinil) FDA Approval History

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