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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/03/07 | Phase 3 | Recruiting | |||
2022/12/15 | Phase 4 | UNKNOWN | |||
2022/09/10 | Phase 4 | Completed | |||
2021/12/03 | Phase 1 | UNKNOWN | |||
2021/06/24 | Phase 3 | Completed | |||
2021/06/11 | Phase 4 | Completed | |||
2020/12/03 | Phase 3 | Active, not recruiting | Dr. Grace Parraga | ||
2019/04/02 | Phase 4 | Completed | |||
2018/09/17 | Not Applicable | Completed | |||
2018/03/27 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Prasco Laboratories | 66993-136 | RESPIRATORY (INHALATION) | 200 ug in 1 1 | 2/24/2022 | |
| GlaxoSmithKline LLC | 0173-0887 | RESPIRATORY (INHALATION) | 100 ug in 1 1 | 9/9/2020 | |
| GlaxoSmithKline LLC | 0173-0888 | RESPIRATORY (INHALATION) | 50 ug in 1 1 | 3/1/2023 | |
| GlaxoSmithKline LLC | 0173-0859 | RESPIRATORY (INHALATION) | 100 ug in 1 1 | 5/12/2023 | |
| GlaxoSmithKline LLC | 0173-0893 | RESPIRATORY (INHALATION) | 200 ug in 1 1 | 9/9/2020 | |
| GlaxoSmithKline LLC | 0173-0876 | RESPIRATORY (INHALATION) | 200 ug in 1 1 | 3/1/2023 | |
| Prasco Laboratories | 66993-135 | RESPIRATORY (INHALATION) | 100 ug in 1 1 | 2/24/2022 | |
| GlaxoSmithKline LLC | 0173-0882 | RESPIRATORY (INHALATION) | 200 ug in 1 1 | 5/12/2023 | |
| Physicians Total Care, Inc. | 54868-6168 | NASAL | 27.5 ug in 1 1 | 9/20/2010 | |
| GlaxoSmithKline LLC | 0173-0916 | RESPIRATORY (INHALATION) | 50 ug in 1 1 | 5/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/13/2013 | ||
Authorised | 5/2/2014 | ||
Authorised | 11/15/2017 | ||
Authorised | 11/15/2017 | ||
Authorised | 1/11/2008 | ||
Authorised | 1/11/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RELVAR ELLIPTA INHALATION POWDER 200MCG/25MCG | SIN14737P | POWDER, METERED | 200 mcg/dose | 2/24/2015 | |
| Avamys Nasal Spray 27.5 mcg/spray | SIN13666P | SPRAY, SUSPENSION | 0.0275mg/spray | 6/23/2009 | |
| RELVAR ELLIPTA INHALATION POWDER 100MCG/25MCG | SIN14736P | POWDER, METERED | 100 mcg/dose | 2/24/2015 | |
| TRELEGY ELLIPTA INHALATION POWDER 100 MCG/62.5 MCG/25 MCG | SIN15806P | POWDER, METERED | 100 mcg | 9/12/2019 | |
| TRELEGY ELLIPTA INHALATION POWDER 200 MCG/62.5 MCG/25 MCG | SIN16914P | POWDER, METERED | 200 MCG | 12/15/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| RELVAR ELLIPTA INHALATION POWDER, PRE-DISPENSED 100MCG/25MCG | N/A | N/A | N/A | 3/12/2014 | |
| RELVAR ELLIPTA INHALATION POWDER, PRE-DISPENSED 200MCG/25MCG | N/A | N/A | N/A | 3/12/2014 | |
| AVAMYS NASAL SPRAY 27.5MCG/SPRAY | N/A | N/A | N/A | 6/20/2008 | |
| FLUTICASONE FUROATE NITTO NASAL SPRAY 27.5MCG/SPRAY | N/A | N/A | N/A | 6/25/2025 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TRELEGY ELLIPTA | 02515776 | Powder - Inhalation | 200 MCG / ACT | 9/13/2021 | |
| TRELEGY ELLIPTA | 02474522 | Powder - Inhalation | 100 MCG / ACT | 5/30/2018 | |
| ARNUITY ELLIPTA | 02446588 | Powder - Inhalation
,
Oral | 200 MCG / ACT | 12/14/2015 | |
| AVAMYS | 02298589 | Spray, Metered Dose - Nasal | 27.5 MCG / ACT | 10/22/2007 | |
| BREO ELLIPTA | 02408872 | Powder - Inhalation | 100 MCG / ACT | 11/29/2013 | |
| BREO ELLIPTA | 02444186 | Powder - Inhalation | 200 MCG / ACT | 10/2/2015 | |
| ARNUITY ELLIPTA | 02446561 | Powder - Oral
,
Inhalation | 100 MCG / ACT | 1/26/2016 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.