Orenitram

Treats pulmonary arterial hypertension (PAH) (WHO Group 1). NDA 203496, held by United Therap. Treprostinil Diolamine.

As of Nov 13, 2026, NDA 203496 (Orenitram), held by United Therap, was first approved by FDA on Dec 20, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2013
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). 1.1 Pulmonary Arterial Hypertension

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Oct 18, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 28, 2016	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 20, 2013	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

5 strengths and forms


OrenitramEQ 0.125MG BASE · tablet, extended release;oral	Treprostinil Diolamine	RxReference drug
OrenitramEQ 0.25MG BASE · tablet, extended release;oral	Treprostinil Diolamine	RxReference drug
OrenitramEQ 1MG BASE · tablet, extended release;oral	Treprostinil Diolamine	RxReference drug
OrenitramEQ 2.5MG BASE · tablet, extended release;oral	Treprostinil Diolamine	RxReference drug
OrenitramEQ 5MG BASE · tablet, extended release;oral	Treprostinil Diolamine	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Aug 4, 2026	Supplement 17Manufacturing · Standard review	Approved	Label
Nov 3, 2020	Supplement 13Manufacturing · Standard review	Approved	Letter Label
Oct 18, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 7, 2017	Supplement 7Labeling · Standard review	Approved	Letter Label
Jan 24, 2017	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 28, 2016	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 6, 2014	Supplement 1Manufacturing · Standard review	Approved	Label Letter
Dec 20, 2013	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 203496
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