Overview
Fluticasone propionate is a synthetic glucocorticoid. These drugs are available as inhalers, nasal, sprays, and topical treatments for various inflammatory indications. Fluticasone propionate was first approved in 1990.
Indication
Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxisas well as inflammatory and pruritic dermatoses. Fluticasone propionate nasal spray is indicated for managing allergic and nonallergic rhinitis.
Associated Conditions
- Allergic Rhinitis (AR)
- Allergy to Animal Dander
- Allergy to Mold
- Allergy to Tree Pollen
- Asthma
- Bacterial Sinusitis
- Chronic Bronchitis
- Chronic Obstructive Pulmonary Disease (COPD)
- Chronic Sinusitis
- Dermatitis
- Emphysema
- Eosinophilic Esophagitis
- House Dust Mite Allergy
- House dust allergy
- Itching of the nose
- Nasal Congestion
- Non-Allergic Rhinitis
- Rhinitis
- Rhinitis Perennial
- Rhinorrhoea
- Seasonal Allergic Rhinitis
- Sneezing
- Moderate, severe Perennial Allergic Rhinitis (PAR)
- Moderate, severe Seasonal Allergic Rhinitis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/07/08 | Phase 4 | UNKNOWN | Xijing Hospital | ||
2021/05/13 | Phase 3 | Completed | Susanna Naggie, MD | ||
2021/02/11 | Phase 4 | Completed | |||
2020/12/21 | Phase 4 | Completed | |||
2020/12/19 | Phase 2 | Completed | |||
2020/12/17 | Phase 4 | Withdrawn | |||
2020/12/14 | Phase 3 | Completed | |||
2020/10/23 | Phase 4 | Withdrawn | |||
2020/09/25 | Phase 1 | Completed | |||
2020/09/11 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0332 | TOPICAL | 0.5 mg in 1 g | 1/23/2019 | |
Physicians Total Care, Inc. | 54868-5995 | RESPIRATORY (INHALATION) | 44 ug in 1 1 | 1/16/2012 | |
GlaxoSmithKline LLC | 0173-0720 | RESPIRATORY (INHALATION) | 220 ug in 1 1 | 1/7/2019 | |
Teva Respiratory, LLC | 59310-505 | RESPIRATORY (INHALATION) | 55 ug in 1 1 | 9/27/2022 | |
Teva Pharmaceuticals USA, Inc. | 0093-7516 | RESPIRATORY (INHALATION) | 500 ug in 1 1 | 9/28/2022 | |
Proficient Rx LP | 63187-638 | NASAL | 50 ug in 1 1 | 6/1/2022 | |
Physicians Total Care, Inc. | 54868-5337 | TOPICAL | 0.5 mg in 1 g | 9/6/2011 | |
Prasco Laboratories | 66993-088 | RESPIRATORY (INHALATION) | 230 ug in 1 1 | 8/1/2022 | |
A-S Medication Solutions | 50090-3387 | RESPIRATORY (INHALATION) | 232 ug in 1 1 | 9/28/2022 | |
NuCare Pharmaceuticals,Inc. | 68071-4156 | NASAL | 50 ug in 0.1 g | 2/15/2021 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
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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 |
---|---|---|---|---|---|
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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TGA Drug Approvals
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PMS-FLUTICASONE | 02503174 | Powder - Inhalation | 500 MCG / ACT | N/A | |
ARBESDA RESPICLICK | teva canada limited | 02474611 | Powder (Metered Dose) - Inhalation | 55 MCG / ACT | N/A |
ALLERGY RELIEF NASAL SPRAY | 02460475 | Spray, Metered Dose - Nasal | 50 MCG / ACT | N/A | |
FLOVENT HFA | 02244292 | Metered-Dose Aerosol - Inhalation
,
Oral | 125 MCG / ACT | 12/20/2001 | |
CUTIVATE | 02089912 | Cream - Topical | 0.05 % | 11/8/2004 | |
FLOVENT HFA | 02244291 | Metered-Dose Aerosol - Oral
,
Inhalation | 50 MCG / ACT | 12/20/2001 | |
AERMONY RESPICLICK | teva canada limited | 02467895 | Powder (Metered Dose) - Inhalation | 55 MCG / ACT | 9/30/2020 |
WIXELA INHUB | Mylan Pharmaceuticals ULC | 02495619 | Powder - Inhalation | 500 MCG / ACT | 2/13/2020 |
WIXELA INHUB | Mylan Pharmaceuticals ULC | 02495597 | Powder - Inhalation | 100 MCG / ACT | 2/13/2020 |
APO-FLUTICASONE HFA | 02528428 | Aerosol, Metered Dose - Inhalation
,
Oral | 50 MCG / ACT | 2/27/2025 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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