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FDA Approves United Therapeutics (UTHR) ADCIRCA Tablets for the Treatment of Pulmonary Arterial Hypertension

May 26, 2009 7:59 AM EDT
UTHR Hot Sheet
Overall Analyst Rating:
    NEUTRAL (= Flat)

EPS Growth %: +2.3%
United Therapeutics Corporation (Nasdaq: UTHR) announced that the FDA has approved ADCIRCA (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). ADCIRCA is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

"Today, thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an effective, convenient and economical therapy for PAH patients," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "The FDA's action in approving once-a-day ADCIRCA is a big plus for all three P's: patients, physicians and payors."

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