Application 214324

Type
NDA
Sponsor
UNITED THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYVASO DPITREPROSTINILPOWDER;INHALATION16MCGYesNo
002TYVASO DPITREPROSTINILPOWDER;INHALATION0.032MG/INHYesYes
003TYVASO DPITREPROSTINILPOWDER;INHALATION0.048MG/INHYesYes
004TYVASO DPITREPROSTINILPOWDER;INHALATION0.064MG/INHYesYes
005TYVASO DPITREPROSTINILPOWDER;INHALATION0.08MG/INHYesYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214324-001TYVASO DPITREPROSTINIL0.016MG/INHPOWDER / INHALATIONRLD, RS2022-05-23
N214324-002TYVASO DPITREPROSTINIL0.032MG/INHPOWDER / INHALATIONRLD, RS2022-05-23
N214324-003TYVASO DPITREPROSTINIL0.048MG/INHPOWDER / INHALATIONRLD, RS2022-05-23
N214324-004TYVASO DPITREPROSTINIL0.064MG/INHPOWDER / INHALATIONRLD, RS2022-05-23
N214324-005TYVASO DPITREPROSTINIL0.08MG/INHPOWDER / INHALATIONRLD, RS2024-10-24

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214324-001113577822027-05-14U-18492025-04-24
N214324-001117238872028-12-15Drug substance2023-08-15
N214324-00195930662028-12-15Drug substance2022-06-17
N214324-001107728832030-06-11Drug product2022-06-17
N214324-001104217292035-04-01Drug product2022-06-17
N214324-001118263272042-02-03U-37492023-11-28
N214324-002113577822027-05-14U-18492025-04-24
N214324-002117238872028-12-15Drug substance2023-08-15
N214324-00295930662028-12-15Drug substance2022-06-17
N214324-002107728832030-06-11Drug product2022-06-17
N214324-002104217292035-04-01Drug product2022-06-17
N214324-002118263272042-02-03U-37492023-11-28
N214324-003113577822027-05-14U-18492025-04-24
N214324-003117238872028-12-15Drug substance2023-08-15
N214324-00395930662028-12-15Drug substance2022-06-17
N214324-003107728832030-06-11Drug product2022-06-17
N214324-003104217292035-04-01Drug product2022-06-17
N214324-003118263272042-02-03U-37492023-11-28
N214324-004113577822027-05-14U-18492025-04-24
N214324-004117238872028-12-15Drug substance2023-08-15
N214324-00495930662028-12-15Drug substance2022-06-17
N214324-004107728832030-06-11Drug product2022-06-17
N214324-004104217292035-04-01Drug product2022-06-17
N214324-004118263272042-02-03U-37492023-11-28
N214324-005113577822027-05-14U-18492025-04-24
N214324-005117238872028-12-15Drug substance2024-11-18
N214324-00595930662028-12-15Drug substance2024-11-18
N214324-005107728832030-06-11Drug product2024-11-18
N214324-005104217292035-04-01Drug product2024-11-18
N214324-005118263272042-02-03U-37492024-11-18

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tyvaso DPITREPROSTINILUnited Therapeutics Corporationddc3d400-bcb3-4b09-aae2-0768b10a5b0f2025-11-20Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Tyvaso DPI may cause symptomatic hypotension. ( 5.1 ) Tyvaso DPI inhibits platelet aggregation and increases the risk of bleeding. ( 5.2 ) Tyvaso DPI dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ( 5.3 , 7.3 ) May cause bronchospasm: Patients with a history of hyperreactive airway disease may be more sensitive. ( 5.4 ) 5.1 Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Tyvaso DPI may produce symptomatic hypotension. 5.2 Risk of Bleeding Tyvaso DPI inhibits platelet aggregation and increases the risk of bleeding. 5.3 Effect of Other Drugs on Treprostinil Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both C max and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . 5.4 Bronchospasm Like other inhaled prostaglandins, Tyvaso DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with Tyvaso DPI.

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following potential adverse reactions are described in Warnings and Precautions (5): - Decrease in systemic blood pressure [see Warnings and Precautions (5.1) ] . - Bleeding [see Warnings and Precautions (5.2) ] . Most common adverse reactions (≥4%) are cough, headache, throat irritation/pharyngolaryngeal pain, nausea, flushing, dyspnea, and syncope. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Pulmonary Arterial Hypertension Tyvaso DPI In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of Tyvaso Inhalation Solution who switched to a corresponding dose of Tyvaso DPI, the most commonly reported adverse events on Tyvaso DPI during the 3-week treatment phase included cough, headache, dyspnea, and nausea. Patient tolerability, as assessed by incidence of new adverse events following transition to Tyvaso DPI, was consistent with the expected known safety profile of Tyvaso Inhalation Solution. Table 1 lists the adverse events that occurred at a rate of at least 4%. Table 1: Adverse Events in ≥4% of PAH Patients Receiving Tyvaso DPI in BREEZE (Treatment Phase) Adverse Event Tyvaso DPI (n=51) n (%) Cough 18 (35.3) Headache 8 (15.7) Dyspnea 4 (7.8) Nausea 3 (5.9) The safety of Tyvaso DPI was also studied in an extension phase of the study in which 49 patients were dosed for a duration of 43 patient-years. Fifty-nine percent (59%) of patients achieved a dose of 64 mcg, 4 times daily or higher. The adverse events during this long-term, extension phase were similar to those observed in the 3-week treatment phase. Tyvaso Inhalation Solution In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most commonly reported adverse reactions on Tyvaso Inhalation Solution included cough and throat irritation, headache, gastrointestinal effects, muscle, jaw or bone pain, dizziness, flushing, and syncope. Table 2 ...

adverse reactions table

Table 1: Adverse Events in ≥4% of PAH Patients Receiving Tyvaso DPI in BREEZE (Treatment Phase)Adverse EventTyvaso DPI (n=51) n (%)Cough18 (35.3)Headache8 (15.7)Dyspnea4 (7.8)Nausea3 (5.9)

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66302-600Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-610Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-616Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-620Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-632Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-648Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-664Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-716Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-720Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-732Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-748Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-764Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71519ORIG2022-07-06
71138ORIG2022-05-24
71137ORIG2022-05-24