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United Therapeutics Corporation Withdraws European Marketing Authorization Application for Tyvaso for the Treatment of Pulmonary Arterial Hypertension
Date:2/19/2010

clinical sites would preclude a recommendation by the EMA for approval of the MAA for Tyvaso.

"Notwithstanding the fact that the EMA's major objection noted findings of non-compliance with good clinical practices, it is important to note that there were no major objections related to the safety or efficacy of Tyvaso," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer.

"Our revenue growth targets are unaffected by the withdrawal," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer.  "We have long based our growth targets on the estimated 30,000 diagnosed PAH patients in the US, including approximately 12,000 New York Heart Association Class III patients."

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