Fluticasone propionate

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
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps	2025/02/27	NCT06850805	Phase 3	Recruiting	Optinose US Inc.
Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE	2024/11/26	NCT06705387	Phase 2	Recruiting	University of Colorado, Denver
CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma	2024/07/01	NCT06482294	Phase 2	Active, not recruiting	Università degli Studi di Ferrara
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma	2024/04/18	NCT06372496	Phase 4	Active, not recruiting	GlaxoSmithKline
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)	2024/01/31	NCT06234345	Phase 3	Not yet recruiting	Eurofarma Laboratorios S.A.
Advair HFA in Healthy and HAPE Predisposed Subjects	2023/09/15	NCT06040268	Phase 1	Recruiting	University of Colorado, Denver
Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers	2023/09/06	NCT06025214	Phase 1	Recruiting	Respirent Pharmaceuticals Co Ltd.
Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers	2023/08/09	NCT05982990	Phase 1	Active, not recruiting	Respirent Pharmaceuticals Co Ltd.
BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)	2023/06/28	NCT05922761	Phase 2	Recruiting	Dana-Farber Cancer Institute
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone)	2023/02/21	NCT05736874	Phase 3	Completed	Susanna Naggie, MD

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CHILDRENS FLUTICASONE PROPIONATE	Aurohealth LLC	58602-018	NASAL	50 ug in 1 1	5/21/2025
Fluticasone Propionate	Cosette Pharmaceuticals, Inc.	0713-0632	TOPICAL	0.05 mg in 1 g	11/22/2023
Fluticasone Propionate	REMEDYREPACK INC.	70518-1655	NASAL	50 ug in 1 1	2/22/2024
AirDuo Digihaler	Teva Respiratory, LLC	59310-129	RESPIRATORY (INHALATION)	113 ug in 1 1	2/9/2024
FLUTICASONE PROPIONATE	Advagen Pharma Ltd	72888-141	NASAL	50 ug in 1 1	6/10/2025
FLUTICASONE PROPIONATE	Proficient Rx LP	63187-959	TOPICAL	0.5 mg in 1 g	12/1/2018
Fluticasone Propionate	Bryant Ranch Prepack	72162-1402	TOPICAL	0.5 mg in 1 g	3/11/2024
Fluticasone Propionate	Golden State Medical Supply, Inc.	60429-195	NASAL	50 ug in 1 1	3/29/2024
Fluticasone Propionate	Glenmark Pharmaceuticals Inc., USA	68462-427	TOPICAL	0.5 mg in 1 mL	2/1/2020
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	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
Seffalair Spiromax	Teva B.V.,Swensweg 5,2031GA Haarlem,The Netherlands	Authorised	3/26/2021
BroPair Spiromax	Teva B.V.,Swensweg 5,2031GA Haarlem,The Netherlands	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	Recipharm HC Limited	SIN14549P	AEROSOL, METERED	50 mcg/actuation	5/19/2014
FLIXOTIDE NEBULES 0.5 mg/2 ml	GLAXOSMITHKLINE AUSTRALIA PTY LTD	SIN11112P	SOLUTION	0.5 mg/2 ml	9/14/1999
SYNAZE NASAL SPRAY	Cipla Limited	SIN15256P	SPRAY, METERED	0.0365 %w/w	6/5/2017
APO-FLUTICASONE AQUEOUS NASAL SPRAY 50MCG/SPRAY	APOTEX INC. (RICHMOND HILL)	SIN13983P	SPRAY, METERED	0.05G/100G	7/5/2011
DYMISTA NASAL SPRAY	Cipla Limited	SIN15255P	SPRAY, METERED	0.0365 %w/w	6/5/2017
SERETIDE 50/100 ACCUHALER 50 mcg/100 mcg	GlaxoSmithKline LLC	SIN11030P	POWDER, METERED	100 mcg/inhalation	7/19/1999
FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 125 MICROGRAM/5 MICROGRAM PER ACTUATION	Recipharm HC Limited	SIN14550P	AEROSOL, METERED	125 mcg/actuation	5/19/2014
CUTIVATE CREAM 0.05% w/w	GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)	SIN08628P	CREAM	0.05% w/w	3/26/1996
FLIXOTIDE EVOHALER 125 mcg	GLAXO WELLCOME PRODUCTION, Glaxo Wellcome S.A.	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
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
SERETIDE INHALER 25/50	N/A	葛兰素史克	N/A	N/A	6/29/2001
SEROFLO 125 INHALER	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/29/2003
SERETIDE ACCUHALER 50MCG/250MCG	N/A	葛兰素史克	N/A	N/A	4/26/1999
SEROFLO 250 INHALER	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/29/2003
ALLEGRO NASAL SPRAY 0.05%	N/A	GAILY PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	2/8/2010
SEROFLO 500 MULTI-HALER POWDER FOR INHALATION 50MCG/500MCG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	10/20/2014
SEROFLO 100 MULTI-HALER POWDER FOR INHALATION 50MCG/100MCG	N/A	CONTROLLED MEDICATIONS LIMITED	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	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	9/28/2017
DALMAN AQ NASAL SPRAY 50MCG/DOSE	N/A	Healthcare Pharma Limited	N/A	N/A	12/11/2006

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DYLASTINE 125/50 azelastine (as hydrochloride) 125 microgram and fluticasone propionate 50 microgram nasal spray bottle	203132	Viatris Pty Ltd	Medicine	A	1/14/2014
SERETIDE ACCUHALER 500/50 powder for inhalation blister	70174	GlaxoSmithKline Australia Pty Ltd	Medicine	A	2/8/2000
SALPLUSF DPI 250/50 fluticasone propionate/salmeterol 250/50 mcg/dose inhalation powder pre-dispensed BP plastic inhaler	418491	Cipla Australia Pty Ltd	Medicine	A	1/3/2024
FLUTICASONE SALMETEROL MULTIHALER 500/50 fluticasone propionate 500 microgram/salmeterol (as xinfoate) 50 microgram powder for inhalation blister pack	371361	Cipla Australia Pty Ltd	Medicine	A	9/29/2022
SEROFLO CIPHALER 500/50 fluticasone propionate 500 microgram / salmeterol (as xinfoate) 50 microgram powder for inhalation blister pack	371360	Cipla Australia Pty Ltd	Medicine	A	9/29/2022
SERETIDE MDI 125/25 inhalation - pressurised aerosol can - metered dose (with counter)	120662	GlaxoSmithKline Australia Pty Ltd	Medicine	A	9/26/2005
FLUTICASONE CIPLA INHALER fluticasone propionate 250 microgram/actuation inhalation pressurised aerosol can metered dose	270516	Cipla Australia Pty Ltd	Medicine	A	2/21/2017
SALFLUMIX EASYHALER 250/50 fluticasone propionate/salmeterol (as xinafoate) 250ug/50ug Powder for inhalation Dry Powder Inhaler	338157	Orion Pharma (AUS) Pty Limited	Medicine	A	10/28/2022
FLIXONASE ALLERGY & HAYFEVER 24 HOUR fluticasone propionate 50ug/actuation aqueous nasal spray bottle	72724	Haleon Australia Pty Ltd	Medicine	A	2/14/2000
APOHEALTH ALLERGY AND HAYFEVER RELIEF NASAL SPRAY bottle	469735	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/21/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-FLUTICASONE HFA	Apotex Inc	02510987	Metered-Dose Aerosol - Oral , Inhalation	250 MCG / ACT	4/26/2021
PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI	Pharmascience Inc	02494515	Powder - Inhalation	250 MCG / ACT	3/5/2020
FLONASE AEM-SUS 50MCG/AEM	glaxo canada inc	02048043	Suspension , Metered-Dose Aerosol - Nasal	50 MCG / ACT	12/31/1993
FLOVENT INHALERS-AEM INH-ORL250MCG/ACTUATION	glaxo canada inc	02174774	Metered-Dose Aerosol - Inhalation , Oral	250 MCG / ACT	12/31/1995
FLOVENT INHALERS-AEM INH-ORL 50MCG/ACTUATION	glaxo canada inc	02174758	Metered-Dose Aerosol - Oral , Inhalation	50 MCG / ACT	12/31/1995
RATIO-FLUTICASONE	teva canada limited	02296071	Metered-Dose Pump - Nasal	50 MCG / ACT	6/7/2007
PMS-FLUTICASONE HFA	Pharmascience Inc	02503131	Metered-Dose Aerosol - Inhalation , Oral	250 MCG / ACT	1/21/2021
ADVAIR	GlaxoSmithKline Inc	02245126	Aerosol, Metered Dose - Inhalation	125 MCG / ACT	12/21/2001
FLOVENT HFA	GlaxoSmithKline Inc	02244293	Metered-Dose Aerosol - Inhalation , Oral	250 MCG / ACT	12/20/2001
FLOVENT INHALERS-AEM INH-ORL 25MCG/ACTUATION	glaxo canada inc	02174731	Metered-Dose Aerosol - Inhalation , Oral	25 MCG / ACT	12/31/1995

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.

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