Tyvaso Dpi

NDA 214324, held by United Therap. Treprostinil.

As of Nov 14, 2026, NDA 214324 (Tyvaso Dpi), held by United Therap, was first approved by FDA on May 23, 2022, with 1 approved supplement and 1 published complete response letter.

First approved: May 23, 2022
Review: Priority
Supplements approved: 1
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 23, 2022	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Oct 15, 2021	TreprostinilFacility Inspections	Approved

Products

5 strengths and forms


Tyvaso Dpi0.016MG/INH · powder;inhalation	Treprostinil	RxReference drug
Tyvaso Dpi0.032MG/INH · powder;inhalation	Treprostinil	RxReference drug
Tyvaso Dpi0.048MG/INH · powder;inhalation	Treprostinil	RxReference drug
Tyvaso Dpi0.064MG/INH · powder;inhalation	Treprostinil	RxReference drug
Tyvaso Dpi0.08MG/INH · powder;inhalation	Treprostinil	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Sep 23, 2026	Supplement 7Labeling · Standard review	Approved	Letter Label
May 23, 2022	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 214324
Drugs@FDA: Overview at FDA
Company: United Therap

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters