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Tyvaso FDA Approval History

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 indicated for the treatment of:
  • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

Development Timeline for Tyvaso

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.