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2017/12/19 | Phase 3 | Withdrawn | |||
2017/12/06 | Phase 4 | Withdrawn | |||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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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |