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FDA Delays Review of Inhaled Treprostinil

SILVER SPRING, Md., March 16, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that, based on its most recent interactions with the U.S. Food and Drug Administration (FDA), the FDA's pending regulatory review of the New Drug Application (NDA) for Tyvaso(TM) (inhaled treprostinil) will likely extend beyond its originally anticipated April 30, 2009, action date. The probable delay relates to questions received from the FDA concerning human factors testing and the instructions for use (IFU) of the OptiNeb(R) portable nebulizer that delivers Tyvaso.

"In response to FDA comments related to our originally submitted instructions for the OptiNeb nebulizer, we provided the FDA with a revised IFU. Following our most recent discussion with the FDA, we have agreed to conduct human factors testing to validate that the revised IFU results in the proper use of the device by a naive user. This relatively small study in normal subjects will test the new IFU in its ability to guide patients to accomplish such tasks as proper device assembly, drug administration, disassembly and cleaning, among other things," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "We are working to get the human factors testing conducted and submitted to the FDA as rapidly as possible, but it is a challenge to complete the study and have it properly reviewed by the FDA in advance of the April 30th action date."

Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer, said, "Given the need to conduct this additional study, we are of the opinion that additional review time is likely. Accordingly, we felt it was our responsibility to inform our shareholders in advance of any 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."

Source: United Therapeutics Corporation

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