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GLAXO WELLCOME FLOLAN REDUCES MORTALITY IN PRIMARY PULMONARY HYPERTENSION; INDICATED FOR CHRONIC USE WITH INDWELLING CENTRAL VENOUS CATHETER

Executive Summary

Glaxo Wellcome's Flolan (epoprostenol for injection) reduces mortality in patients who develop primary pulmonary hypertension, an orphan condition, according to data contained in the company's NDA, approved by FDA Sept. 20. Flolan is indicated for treatment of primary pulmonary hypertension in New York Heart Association Class III and Class IV patients, the first therapy approved for the condition. Flolan was designated "1P" by the agency, denoting a new molecular entity given priority review.
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PS026944

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