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Tyvaso Approval History

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

Tyvaso (treprostinil) is an inhaled prostanoid analogue indicated for the treatment of pulmonary arterial hypertension.

Development History and FDA Approval Process for Tyvaso

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

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