FDA Rejects Oral Prostacyclin Vasodilator for Second Time

The FDA rejected oral treprostinil, a prostacyclin vasodilator, for the second time for the treatment of pulmonary arterial hypertension. The Agency issued a complete response letter to United Therapeutics explaining the rejection. The drug is on the market in injectable and inhalable forms.

Clinical Topics: Clinical Topic Collection: Dyslipidemia, Heart Failure and Cardiomyopathies, Pulmonary Hypertension and Venous Thromboembolism, Lipid Metabolism, Pulmonary Hypertension

Keywords: Epoprostenol, Vasodilator Agents, Hypertension, Pulmonary


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