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Fluticasone furoate

Generic Name
Fluticasone furoate
Brand Names
Arnuity Ellipta, Avamys, Breo Ellipta, Flonase Sensimist, Trelegy Ellipta, Veramyst, Elebrato Ellipta, Relvar Ellipta, Revinty Ellipta
Drug Type
Small Molecule
Chemical Formula
C27H29F3O6S
CAS Number
397864-44-7
Unique Ingredient Identifier
JS86977WNV

Overview

Fluticasone furoate is a synthetic glucocorticoid available as an inhaler and nasal spray for various inflammatory indications. Fluticasone furoate was first approved in 2007.

Background

Fluticasone furoate is a synthetic glucocorticoid available as an inhaler and nasal spray for various inflammatory indications. Fluticasone furoate was first approved in 2007.

Indication

Fluticasone furoate is indicated for once-daily maintenance (i.e. prophylactic) treatment of asthma in patients ≥5 years old. Fluticasone furoate is available in two combination medications - one in combination with vilanterol and one in combination with both vilanterol and umeclidinium- which are both indicated for the management of chronic obstructive pulmonary disease (COPD) and for the treatment of asthma in patients ≥18 years old for the vilanterol-umeclidinium-fluticasone product and ≥5 years old for the vilanterol-fluticasone product. Fluticasone furoate is available over the counter as a nasal spray for the symptomatic treatment of hay fever and other upper respiratory allergies in patients ≥2 years old.

Associated Conditions

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Perennial Allergy
  • Seasonal Allergies

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2018/03/27
Phase 4
Completed
2018/03/22
Phase 4
Completed
2018/03/16
Phase 4
Completed
2017/12/19
Phase 3
Withdrawn
2017/12/06
Phase 4
Withdrawn
2017/10/19
Phase 4
Completed
2017/06/12
N/A
Completed
2017/01/06
Phase 2
Completed
2016/12/23
Phase 2
Active, not recruiting
2016/09/07
Phase 4
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
GlaxoSmithKline LLC
0173-0874
RESPIRATORY (INHALATION)
100 ug in 1 1
3/1/2023

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
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Status
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