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Tyvaso FDA Approval History

Last updated by Judith Stewart, BPharm on June 1, 2022.

FDA Approved: Yes (First approved July 30, 2009)
Brand name: Tyvaso
Generic name: treprostinil
Dosage form: Inhalation Solution
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension

Tyvaso (treprostinil) is a prostacyclin mimetic used for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

  • Tyvaso is indicated for the treatment of:
    • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
    • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).
  • Tyvaso is administered via the Tyvaso Inhalation System in 4 separate treatment sessions each day approximately 4 hours apart, during waking hours.
  • Warnings and precautions include symptomatic hypotension, increased risk of bleeding, and bronchospasm.
  • Common adverse reactions include cough, headache, nausea, dizziness, flushing, throat irritation, pharyngolaryngeal pain, diarrhea, and syncope.

Development timeline for Tyvaso

May 25, 2022Approval United Therapeutics Announces FDA Approval of Tyvaso DPI
Apr  1, 2021Approval United Therapeutics Announces FDA Approval and Launch of Tyvaso for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Jul 30, 2009Approval FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension
Apr 28, 2009U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months
Mar 16, 2009United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
Sep  3, 2008Inhaled Treprostinil New Drug Application Filed by FDA
Jun 30, 2008New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration

Further information

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