United Therapeutics Remodulin “approvable”
Executive Summary
United Therapeutics will conduct a two-year postmarketing study for its pulmonary arterial hypertension therapy Remodulin (treprostinil) after an FDA "approvable" letter. The Cardio-Renal Advisory Committee found that secondary measures in the pivotal trial suggested efficacy which could support accelerated approval (1"The Pink Sheet" Aug. 13, 2001, p. 21). The company expects approval in several months, following labeling discussions...