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FDA declines approval of United Therapeutics’ Tyvaso after inspection issue CPhIonline
October 22, 2021
The US Food and Drug Administration has declined to approve United Therapeutics’ Tyvaso (Treprostinil) dry powder inhalation drug-device combination treatment for pulmonary arterial hypertension...
United Therapeutics Receives Orphan Drug Designation for Treprostinil for Idiopathic Pulmonary Fibrosis americanpharmaceuticalreview
December 30, 2020
United Therapeutics announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
FDA Accepts sNDA for Tyvaso from United Therapeutics americanpharmaceuticalreview
August 21, 2020
United Therapeutics announced the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with ...