Expanded label approved for Remodulin

March 27, 2006

Already approved as a subcutaneous or intravenous infusion for the treatment of pulmonary arterial hypertension (PAH), treprostinil sodium (Remodulin, United Therapeutics) for injection has received expanded label approval from the FDA and can now also be used to diminish the rate of clinical deterioration in patients requiring transition from epoprostenol sodium (Flolan, GlaxoSmithKline). United Therapeutics said it has also successfully completed a phase IV postmarketing study as part of an FDA Subpart H accelerated approval requirement.

Expanded label approved for Remodulin

Already approved as a subcutaneous or intravenous infusion for the treatment of pulmonary arterial hypertension (PAH), treprostinil sodium (Remodulin, United Therapeutics) for injection has received expanded label approval from the FDA and can now also be used to diminish the rate of clinical deterioration in patients requiring transition from epoprostenol sodium (Flolan, GlaxoSmithKline). United Therapeutics said it has also successfully completed a phase IV postmarketing study as part of an FDA Subpart H accelerated approval requirement. The company's president said the study results confirm the clinical benefit of Remodulin in PAH patients, provide expanded labeling specific to Flolan transition, and remove the drug's conditional approval status.

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