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 |
|---|---|---|---|---|---|
2023/01/25 | Phase 1 | Active, not recruiting | |||
2023/01/13 | Phase 3 | Not yet recruiting | EMS | ||
2022/12/23 | Phase 3 | Recruiting | |||
2022/12/02 | Phase 3 | Active, not recruiting | Ellodi Pharmaceuticals, LP | ||
2022/11/08 | Phase 1 | Recruiting | |||
2022/09/10 | Phase 2 | Recruiting | John Harris | ||
2022/07/14 | N/A | Active, not recruiting | |||
2022/07/06 | Phase 4 | Completed | |||
2022/05/31 | Phase 1 | UNKNOWN | |||
2022/05/05 | Phase 3 | UNKNOWN | Glenmark Pharmaceuticals Ltd. India |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 68788-8446 | NASAL | 50 ug in 1 1 | 5/18/2023 | |
| Strategic Sourcing Services LLC | 70677-1021 | NASAL | 50 ug in 1 1 | 5/22/2025 | |
| Asclemed USA, Inc. | 76420-106 | NASAL | 50 ug in 0.1 g | 10/12/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3608 | RESPIRATORY (INHALATION) | 113 ug in 1 1 | 2/9/2024 | |
| Physicians Total Care, Inc. | 54868-4517 | RESPIRATORY (INHALATION), ORAL | 250 ug in 1 1 | 11/12/2010 | |
| Direct RX | 61919-611 | NASAL | 50 ug in 1 1 | 4/9/2019 | |
| Preferred Pharmaceuticals, Inc. | 68788-9678 | NASAL | 50 ug in 1 1 | 6/14/2023 | |
| GlaxoSmithKline LLC | 0173-0697 | RESPIRATORY (INHALATION) | 500 ug in 1 1 | 10/20/2020 | |
| H.J. Harkins Company, Inc. | 76519-1177 | RESPIRATORY (INHALATION) | 100 ug in 1 1 | 4/30/2019 | |
| Blenheim Pharmacal, Inc. | 10544-653 | NASAL | 50 ug in 1 1 | 4/17/2015 |
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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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FLIXOTIDE EVOHALER 50 mcg | SIN11358P | AEROSOL, SPRAY | 50 mcg | 7/27/2000 | |
| FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 250 MICROGRAM/10 MICROGRAM PER ACTUATION | SIN14551P | AEROSOL, METERED | 250 mcg/actuation | 5/19/2014 | |
| SALFLUMIX EASYHALER INHALATION POWDER 50µG/500µG/DOSE | SIN16910P | POWDER, METERED | 500µg/dose | 12/13/2023 | |
| SALFLUMIX EASYHALER INHALATION POWDER 50µG/250µG/DOSE | SIN16909P | POWDER, METERED | 250µg/dose | 12/13/2023 | |
| SERETIDE 50/250 ACCUHALER 50 mcg/250 mcg | SIN11031P | POWDER, METERED | 250 mcg/inhalation | 7/19/1999 | |
| SERETIDE EVOHALER 25/250 mcg | SIN11531P | AEROSOL, SPRAY | 250 mcg | 5/24/2001 | |
| SERETIDE EVOHALER 25/50 mcg | SIN11529P | AEROSOL, SPRAY | 50 mcg | 5/24/2001 | |
| SERETIDE 50/500 ACCUHALER 50 mcg/500 mcg | SIN11032P | POWDER, METERED | 500 mcg/inhalation | 7/19/1999 | |
| SERETIDE EVOHALER 25/125 mcg | SIN11530P | AEROSOL, SPRAY | 125 mcg | 5/24/2001 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fluticasone Propionate Cream | 国药准字HC20150022 | 化学药品 | 乳膏剂 | 12/1/2023 | |
| Fluticasone Propionate Cream | 国药准字H20173270 | 化学药品 | 乳膏剂 | 7/25/2022 | |
| Fluticasone Propionate Cream | 国药准字H20103337 | 化学药品 | 乳膏剂 | 4/26/2020 | |
| Fluticasone Propionate Cream | 国药准字H20103501 | 化学药品 | 乳膏剂 | 5/19/2020 | |
| Fluticasone Propionate Cream | H20130431 | 化学药品 | 乳膏剂 | 11/15/2019 | |
| Fluticasone Propionate Nasal Spray | 国药准字HJ20140117 | 化学药品 | 鼻喷雾剂 | 9/17/2020 | |
| Fluticasone Propionate Nasal Spray | 国药准字H20253887 | 化学药品 | 鼻用制剂 | 4/15/2025 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FLIXOTIDE INHALER 250MCG | N/A | N/A | N/A | 10/3/1994 | |
| SERETIDE INHALER 25/250 | N/A | N/A | N/A | 6/29/2001 | |
| FLIXONASE AQ NASAL SPRAY 0.05% | N/A | N/A | N/A | 2/23/2001 | |
| SERETIDE INHALER 25/125 | N/A | N/A | N/A | 6/29/2001 | |
| FLUTICASONE PROPIONATE PRESSURIZED INHALATION SUSPENSION 250MCG/DOSE | N/A | N/A | N/A | 5/23/2022 | |
| SERETIDE ACCUHALER 50MCG/500MCG | N/A | N/A | N/A | 4/26/1999 | |
| FLIXOTIDE INHALER 50MCG | N/A | N/A | N/A | 10/3/1994 | |
| SEROFLO 50 INHALER | N/A | N/A | N/A | 8/29/2003 | |
| SERETIDE ACCUHALER 50MCG/100MCG | N/A | N/A | N/A | 4/26/1999 | |
| CUTIVATE CREAM 0.05% | N/A | N/A | N/A | 6/9/1994 |
TGA Drug Approvals
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