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FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension
Date:7/30/2009

o a Post-Marketing Requirement (PMR) to conduct a long-term observational study to evaluate the risk of oropharyngeal and pulmonary toxicities among patients using TYVASO. "We welcome the opportunity to gather further information on TYVASO's safety," continued Dr. Jeffs. We have committed to complete the PMR no later than December 15, 2013.

In the TRIUMPH-1 randomized, double-blind, 12-week placebo-controlled clinical trial, patients taking TYVASO in four daily inhalation sessions achieved a 20-meter improvement in six-minute walk distance over those taking placebo (p<0.0005). The safety and effectiveness in patients with underlying lung disease has not been established. The most common side effects (>= 10%) seen with TYVASO in the placebo controlled clinical study were cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain and diarrhea.

United Therapeutics plans to launch TYVASO in conjunction with its wholly-owned subsidiary, Lung Rx, Inc., in the United States at the beginning of September 2009.

Conference Call

United Therapeutics will host a half hour teleconference on July 31, 2009, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 1-877-852-6576, with international callers dialing 1-719-325-4788. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 1-888-203-1112, with international callers dialing 1-719-457-0820, and using conference code: 4416949.

This teleconference is also being webcast and can be accessed via United Therapeutics' website at http://ir.unither.com/events.cfm.

About TYVASO

TYVASO is an inhaled medicine used to treat PAH, a life-threatening disease that constricts the f
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SOURCE United Therapeutics Corporation
Copyright©2009 PR Newswire.
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