Trelegy Ellipta

Treats chronic obstructive pulmonary disease (COPD). NDA 209482, held by Glaxosmithkline. Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate.

As of Nov 13, 2026, NDA 209482 (Trelegy Ellipta), held by Glaxosmithkline, was first approved by FDA on Sep 18, 2017, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 18, 2017
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for:

the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
the maintenance treatment of asthma in patients aged 18 years and older. Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1.3, 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease TRELEGY ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Sep 9, 2020	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 24, 2018	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 18, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Medication Guide

Products

2 strengths and forms

Product	Active ingredient	Marketing
Trelegy Ellipta0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH · powder;inhalation	Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate	RxReference drug
Trelegy Ellipta0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH · powder;inhalation	Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate	RxReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 2, 2023	Supplement 18Labeling · Standard review	Approved	Letter Label
Dec 2, 2022	Supplement 16Labeling · Standard review	Approved	Label Letter
May 11, 2022	Supplement 13Labeling · Standard review	Approved	Letter Label
Sep 9, 2020	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 9, 2020	Supplement 11Labeling · Standard review	Approved	Letter Label
May 15, 2019	Supplement 5Labeling · Standard review	Approved	Letter Label
Jan 7, 2019	Supplement 2Labeling · Standard review	Approved	Label
Jan 7, 2019	Supplement 3Labeling · Standard review	Approved	Letter Label
Apr 24, 2018	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 18, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Medication Guide

Identifiers

Application: NDA 209482
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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