Remodulin

NDA 21272, held by United Therap. Treprostinil.

As of Nov 14, 2026, NDA 21272 (Remodulin), held by United Therap, was first approved by FDA on May 21, 2002, with 15 approved supplements and 0 published complete response letters.

First approved: May 21, 2002
Review: Priority
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Remodulin is a prostacyclin mimetic indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Mar 20, 2006	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Nov 24, 2004	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
May 21, 2002	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

8 strengths and forms


Remodulin1MG/ML · injectable;intravenous, subcutaneous	Treprostinil	RxReference drug
Remodulin2.5MG/ML · injectable;intravenous, subcutaneous	Treprostinil	RxReference drug
Remodulin5MG/ML · injectable;intravenous, subcutaneous	Treprostinil	RxReference drug
Remodulin10MG/ML · injectable;intravenous, subcutaneous	Treprostinil	RxReference drug
Remodulin20MG/ML · injectable;intravenous, subcutaneous	Treprostinil	DiscontinuedReference drug
Remodulin0.1MG/ML · injectable;intravenous, subcutaneous	Treprostinil	DiscontinuedReference drug
Remodulin0.2MG/ML · injectable;intravenous, subcutaneous	Treprostinil	DiscontinuedReference drug
Remodulin0.4MG/ML · injectable;intravenous, subcutaneous	Treprostinil	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Mar 7, 2023	Supplement 37Labeling · Standard review	Approved	Label Letter
Jul 30, 2021	Supplement 32Manufacturing	Approved	Letter Label
Aug 19, 2020	Supplement 30Manufacturing	Tentative approval	Label Letter
Jul 30, 2018	Supplement 25Labeling · Standard review	Approved	Letter Label
Jun 8, 2018	Supplement 26Labeling · Standard review	Approved	Letter Label
Jan 22, 2016	Supplement 22Manufacturing · Priority review	Approved	None posted
Dec 22, 2014	Supplement 19Manufacturing	Approved	Label Letter
Jan 3, 2014	Supplement 21Manufacturing · Priority review	Approved	None posted
Sep 26, 2013	Supplement 20Labeling · Standard review	Approved	Review Letter Label Label
Feb 8, 2011	Supplement 15Labeling	Approved	Letter Label
Jan 8, 2010	Supplement 11Labeling · Standard review	Approved	Letter Label
Sep 12, 2008	Supplement 8Labeling · Standard review	Approved	Label Letter
Feb 4, 2008	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 20, 2006	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jan 20, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Nov 24, 2004	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
May 21, 2002	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 21272
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