Breo Ellipta

Treats chronic obstructive pulmonary disease (COPD). NDA 204275, held by Glaxo Grp Ltd. Fluticasone Furoate; Vilanterol Trifenatate.

As of Nov 14, 2026, NDA 204275 (Breo Ellipta), held by Glaxo Grp Ltd, was first approved by FDA on May 10, 2013, with 11 approved supplements and 0 published complete response letters.

First approved: May 10, 2013
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, 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 5 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 Fluticasone Furoate/Vilanterol 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 12 submissions below


May 12, 2023	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 15, 2017	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 30, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 10, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Breo Ellipta0.1MG/INH;EQ 0.025MG BASE/INH · powder;inhalation	Fluticasone Furoate; Vilanterol Trifenatate	RxReference drug
Breo Ellipta0.2MG/INH;EQ 0.025MG BASE/INH · powder;inhalation	Fluticasone Furoate; Vilanterol Trifenatate	RxReference drug
Breo Ellipta0.05MG/INH;EQ 0.025MG BASE/INH · powder;inhalation	Fluticasone Furoate; Vilanterol Trifenatate	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


May 12, 2023	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 7, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 20, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
May 15, 2017	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 31, 2016	Supplement 11Labeling · Standard review	Approved	Label Letter
Feb 16, 2016	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 21, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 15, 2015	Supplement 4Labeling · Standard review	Approved	Label Letter
Aug 11, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 30, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 2, 2015	Supplement 2Labeling · Standard review	Approved	Label Letter
May 10, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 204275
Drugs@FDA: Overview at FDA
Company: Glaxo Group

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