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
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