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United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
Date:3/16/2009

y formal notice from the FDA. We hope that any delay related to this issue will be limited to just a few months. However, in deference to the regulatory process, we will not be providing further information or status updates on any other aspect of our Tyvaso NDA until we receive a definitive written response from the FDA."

Conference Call

A half-hour teleconference will be held on Monday, March 16, 2009, at 9:00 a.m. Eastern Time to answer questions relating to the probable delay. The teleconference is accessible by dialing 877-852-6578, with international callers dialing 719-325-4820. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 888-203-1112, with international callers dialing 719-457-0820, and using passcode: 4242990.

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

About United Therapeutics

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.

Forward-looking Statements

Statements included in this press release concerning the probability or likelihood of a delay in the FDA's pending review of our NDA for Tyvaso, the reasons for such delay, the expected duration of such delay and our intention to not comment further on the status of Tyvaso's regulatory review until a definitive written response has been received from the FDA are "forward-looking statements" within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are qualif
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SOURCE United Therapeutics Corporation
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