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TYVASO DPI (nda214324)- (0.016MG/INH,0.032MG/INH,0.048MG/INH,0.064MG/INH,0.08MG/INH)

TREPROSTINIL UNITED THERAP
0.016MG/INH,0.032MG/INH,0.048MG/INH,0.064MG/INH,0.08MG/INH
No No
2042-Feb-03 Expired
None 2025-May-23
None No
Tyvaso DPI is a prostacyclin mimetic 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%).
0 0 0
Total Other Developers None
Drugs with Suitability No
0.016MG/INH ** ** - - -
0.032MG/INH ** ** - - -
0.048MG/INH ** ** - - -
0.064MG/INH ** ** - - -
0.08MG/INH ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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