In Brief: Wellcome's Flolan
Executive Summary
Wellcome's Flolan: Reaches "approvable" status at FDA May 9 for long-term I.V. treatment of adults with primary pulmonary hypertension in NYHA Class III and IV patients with congestive heart failure due to severe left ventricular systolic dysfunction. Flolan (epoprostenol) would become the first drug approved for the orphan indication. It was recommended for approval by an FDA advisory committee in February ("The Pink Sheet" Feb. 27, p. 10)...