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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/27 | Phase 3 | Recruiting | |||
2024/11/26 | Phase 2 | Recruiting | |||
2024/07/01 | Phase 2 | Active, not recruiting | Università degli Studi di Ferrara | ||
2024/04/18 | Phase 4 | Active, not recruiting | |||
2024/01/31 | Phase 3 | Not yet recruiting | Eurofarma Laboratorios S.A. | ||
2023/09/15 | Phase 1 | Recruiting | |||
2023/09/06 | Phase 1 | Recruiting | |||
2023/08/09 | Phase 1 | Active, not recruiting | |||
2023/06/28 | Phase 2 | Recruiting | |||
2023/02/21 | Phase 3 | Completed | Susanna Naggie, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aurohealth LLC | 58602-018 | NASAL | 50 ug in 1 1 | 5/21/2025 | |
| Cosette Pharmaceuticals, Inc. | 0713-0632 | TOPICAL | 0.05 mg in 1 g | 11/22/2023 | |
| REMEDYREPACK INC. | 70518-1655 | NASAL | 50 ug in 1 1 | 2/22/2024 | |
| Teva Respiratory, LLC | 59310-129 | RESPIRATORY (INHALATION) | 113 ug in 1 1 | 2/9/2024 | |
| Advagen Pharma Ltd | 72888-141 | NASAL | 50 ug in 1 1 | 6/10/2025 | |
| Proficient Rx LP | 63187-959 | TOPICAL | 0.5 mg in 1 g | 12/1/2018 | |
| Bryant Ranch Prepack | 72162-1402 | TOPICAL | 0.5 mg in 1 g | 3/11/2024 | |
| Golden State Medical Supply, Inc. | 60429-195 | NASAL | 50 ug in 1 1 | 3/29/2024 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-427 | TOPICAL | 0.5 mg in 1 mL | 2/1/2020 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-066 | NASAL | 50 ug in 1 1 | 3/31/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/26/2021 | ||
Authorised | 3/26/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 50 MICROGRAM/5 MICROGRAM PER ACTUATION | SIN14549P | AEROSOL, METERED | 50 mcg/actuation | 5/19/2014 | |
| FLIXOTIDE NEBULES 0.5 mg/2 ml | SIN11112P | SOLUTION | 0.5 mg/2 ml | 9/14/1999 | |
| SYNAZE NASAL SPRAY | SIN15256P | SPRAY, METERED | 0.0365 %w/w | 6/5/2017 | |
| APO-FLUTICASONE AQUEOUS NASAL SPRAY 50MCG/SPRAY | SIN13983P | SPRAY, METERED | 0.05G/100G | 7/5/2011 | |
| DYMISTA NASAL SPRAY | SIN15255P | SPRAY, METERED | 0.0365 %w/w | 6/5/2017 | |
| SERETIDE 50/100 ACCUHALER 50 mcg/100 mcg | SIN11030P | POWDER, METERED | 100 mcg/inhalation | 7/19/1999 | |
| FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 125 MICROGRAM/5 MICROGRAM PER ACTUATION | SIN14550P | AEROSOL, METERED | 125 mcg/actuation | 5/19/2014 | |
| CUTIVATE CREAM 0.05% w/w | SIN08628P | CREAM | 0.05% w/w | 3/26/1996 | |
| FLIXOTIDE EVOHALER 125 mcg | SIN11347P | AEROSOL, SPRAY | 125 mcg | 7/12/2000 | |
| FLIXONASE AQUEOUS NASAL SPRAY 0.05% w/w | GLAXO WELLCOME SA | SIN07090P | SPRAY | 0.05% w/w | 6/22/1992 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fluticasone Propionate Nebuliser Suspension | eddingpharm b.v. | 国药准字HJ20170361 | 化学药品 | 雾化吸入用混悬液 | 1/11/2022 |
| Fluticasone Propionate Nebuliser Suspension | 国药准字H20243929 | 化学药品 | 吸入制剂 | 6/4/2024 | |
| Fluticasone Propionate Nebuliser Suspension | 国药准字H20243731 | 化学药品 | 吸入制剂 | 5/21/2024 | |
| Fluticasone Propionate Nebuliser Suspension | 国药准字H20247005 | 化学药品 | 雾化吸入用混悬液 | 1/8/2024 | |
| Fluticasone Propionate Inhalation Aerosol | 国药准字HJ20130189 | 化学药品 | 吸入气雾剂 | 12/27/2023 | |
| Fluticasone Propionate Inhalation Aerosol | 国药准字HJ20130190 | 化学药品 | 吸入气雾剂 | 12/27/2023 | |
| Fluticasone Propionate Cream | 国药准字H20253814 | 化学药品 | 乳膏剂 | 4/8/2025 | |
| Fluticasone Propionate Cream | 国药准字H20173346 | 化学药品 | 乳膏剂 | 10/26/2022 | |
| Fluticasone Propionate Cream | 国药准字H20244439 | 化学药品 | 乳膏剂 | 7/9/2024 | |
| Fluticasone Propionate Cream | 国药准字HC20150021 | 化学药品 | 乳膏剂 | 12/1/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SERETIDE INHALER 25/50 | N/A | N/A | N/A | 6/29/2001 | |
| SEROFLO 125 INHALER | N/A | N/A | N/A | 8/29/2003 | |
| SERETIDE ACCUHALER 50MCG/250MCG | N/A | N/A | N/A | 4/26/1999 | |
| SEROFLO 250 INHALER | N/A | N/A | N/A | 8/29/2003 | |
| ALLEGRO NASAL SPRAY 0.05% | N/A | N/A | N/A | 2/8/2010 | |
| SEROFLO 500 MULTI-HALER POWDER FOR INHALATION 50MCG/500MCG | N/A | N/A | N/A | 10/20/2014 | |
| SEROFLO 100 MULTI-HALER POWDER FOR INHALATION 50MCG/100MCG | N/A | N/A | N/A | 10/20/2014 | |
| DERMCASONE CREAM 0.05% | N/A | bright future pharmaceuticals factory o/b bright future pharmaceutical laboratories limited | N/A | N/A | 9/5/2007 |
| FUTISON CREAM 0.05% W/W | N/A | N/A | N/A | 9/28/2017 | |
| DALMAN AQ NASAL SPRAY 50MCG/DOSE | N/A | N/A | N/A | 12/11/2006 |
TGA Drug Approvals
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