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Cutivate, Avamys(fluticasone furoate)
Advair, Airduo, Armonair, Avamys, Dymista, Ellipta, Flonase, Flovent, Spiromax, Xhance (fluticasone furoate) is a small molecule pharmaceutical. Fluticasone furoate was first approved as Cutivate on 1990-12-14. It is used to treat allergic rhinitis perennial in the USA. It has been approved in Europe to treat allergic rhinitis perennial, allergic rhinitis seasonal, asthma, and chronic obstructive pulmonary disease.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Armonair, Arnuity ellipta, Flonase, Flonase sensimist, Flovent, Xhance (generic drugs available since 2004-05-14, discontinued: Cutivate)
Combinations
Advair, Airduo, Breo ellipta, Dymista, Trelegy ellipta (generic drugs available since 2004-05-14)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azelastine hydrochloride
+
Fluticasone propionate
Tradename
Company
Number
Date
Products
DYMISTAMylanN-202236 RX2012-05-01
1 products, RLD, RS
Fluticasone furoate
Tradename
Company
Number
Date
Products
ARNUITY ELLIPTAGSKN-205625 RX2014-08-20
3 products, RLD, RS
FLONASE SENSIMIST ALLERGY RELIEFGSKN-022051 OTC2016-08-02
1 products, RLD, RS
Fluticasone furoate
+
Umeclidinium bromide
+
Vilanterol trifenatate
Tradename
Company
Number
Date
Products
TRELEGY ELLIPTAGSKN-209482 RX2017-09-18
2 products, RLD, RS
Fluticasone furoate
+
Vilanterol trifenatate
Tradename
Company
Number
Date
Products
BREO ELLIPTAGSKN-204275 RX2013-05-10
3 products, RLD, RS
Fluticasone propionate
Tradename
Company
Number
Date
Products
FLOVENT DISKUS 50GSKN-020833 RX2000-09-29
1 products, RLD, RS
FLOVENT DISKUS 100GSKN-020833 RX2000-09-29
1 products, RLD, RS
FLOVENT DISKUS 250GSKN-020833 RX2000-09-29
1 products, RLD, RS
FLOVENT HFAGSKN-021433 RX2004-05-14
3 products, RLD, RS
FLONASE ALLERGY RELIEFGSKN-205434 OTC2014-07-23
1 products, RLD
XHANCEOptiNoseN-209022 RX2017-09-18
1 products, RLD, RS
ARMONAIR DIGIHALERTevaN-208798 RX2020-02-20
4 products, RLD, RS
ARMONAIR RESPICLICKTevaN-208798 PEND2021-07-09
1 products, RLD
Show 7 discontinued
Fluticasone propionate
+
Salmeterol xinafoate
Tradename
Company
Number
Date
Products
ADVAIR DISKUS 100/50GSKN-021077 RX2000-08-24
1 products, RLD, RS
ADVAIR DISKUS 250/50GSKN-021077 RX2000-08-24
1 products, RLD, RS
ADVAIR DISKUS 500/50GSKN-021077 RX2000-08-24
1 products, RLD, RS
ADVAIR HFAGSKN-021254 RX2006-06-08
3 products, RLD, RS
AIRDUO DIGIHALERTevaN-208799 RX2019-07-12
3 products, RLD
AIRDUO RESPICLICKTevaN-208799 RX2017-01-27
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
advair hfaNew Drug Application2021-08-25
airduo respiclickNew Drug Application2020-11-23
armonair digihalerNew Drug Application2020-06-22
arnuity elliptaNew Drug Application2020-02-10
breo elliptaNew Drug Application2021-07-26
cutivate New Drug Application2013-06-25
dymistaNew Drug Application2021-04-07
flonase sensimistNew Drug Application2023-04-20
floventNew Drug Application2023-06-07
trelegy elliptaNew Drug Application2020-09-09
Show 3 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis perennialEFO_1001417D012221J30.89
Agency Specific
FDA
EMA
Expiration
Code
FLUTICASONE FUROATE / VILANTEROL TRIFENATATE, BREO ELLIPTA, GLAXO GRP LTD
2026-05-13NPP, NS
FLUTICASONE FUROATE, ARNUITY ELLIPTA, GLAXOSMITHKLINE
2026-03-01M-290
FLUTICASONE PROPIONATE, ARMONAIR DIGIHALER, TEVA PHARM
2025-01-09PED
2024-07-09NPP, NS
FLUTICASONE PROPIONATE, ARMONAIR RESPICLICK, TEVA PHARM
2025-01-09PED
2024-07-09NPP, NS
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO DIGIHALER, TEVA PHARM
2025-01-09PED
2024-07-09M-61
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO RESPICLICK, TEVA PHARM
2025-01-09PED
2024-07-09M-61
FLUTICASONE FUROATE / UMECLIDINIUM BROMIDE / VILANTEROL TRIFENATATE, TRELEGY ELLIPTA, GLAXOSMITHKLINE
2023-09-09I-843, NS
Patent Expiration
Patent
Expires
Flag
FDA Information
Fluticasone Propionate, Armonair Digihaler, Teva Pharm
112667962041-02-22DP
111732592040-07-06DP
114649232040-06-19DP
114397772040-05-24DP
113446852039-09-26DP
110006532038-12-18DP
113579352038-09-24DP
113513172038-02-10DP
105690342036-08-16DP
109188162035-12-14DP
97825502035-08-28DP
97825512035-08-28DP
87141492032-02-25DP
89789662032-01-13DP
105618082032-01-01DP
92162602031-06-28DP
97310872031-05-18DP
100225102031-05-18DP
101241312031-05-18DP
101953752031-02-14DP
86511032028-03-26DP
94632882025-05-19DP
107658202025-05-19DP
96160242024-09-01DP
75402822023-05-06DP
Fluticasone Propionate, Xhance, Optinose Us Inc
115542292036-02-23U-2133
103002292035-07-07DPU-2133
100766142034-10-20DP
104785742033-11-04U-2133
101792162033-07-08DPU-2133
110336962033-05-20DP
102520102031-02-07DP
89786472030-12-06DP
85500732029-10-22DP
100766152029-07-30U-2133
116026032028-10-27DPU-2133
101241322027-03-06DPU-2133
79756902025-12-29U-2133
85227782024-04-20DP
83278442023-10-24U-2133
Fluticasone Propionate / Salmeterol Xinafoate, Airduo Digihaler, Teva Pharm
90669572034-10-06DPU-645
94150082034-10-06DPU-645
99872292024-09-01DP
Fluticasone Furoate / Umeclidinium Bromide / Vilanterol Trifenatate, Trelegy Ellipta, Glaxosmithkline
97507262030-11-29DP
110902942030-11-29U-3202
74888272027-12-18DS, DP
85113042027-06-14DPU-1424, U-1691, U-2954
81832572025-07-27U-2128, U-2129
74393932025-05-21DS, DPU-1401, U-1691, U-2099, U-2100, U-2127, U-2957
74984402025-04-27DS, DP
83095722025-04-27U-2129
RE448742023-03-23DS, DPU-1548, U-1691, U-2127, U-2955
Fluticasone Furoate, Arnuity Ellipta, Glaxosmithkline
87462422030-10-11DP
85342812030-03-08DP
82015562029-02-05DP
81619682028-02-05DP
81131992027-10-23DP
93333102027-10-02DP
Fluticasone Furoate / Vilanterol Trifenatate, Breo Ellipta, Glaxo Grp Ltd
111167212029-02-26DPU-1401, U-1691
Fluticasone Furoate, Flonase Sensimist Allergy Relief, Glaxosmithkline Cons
81474612028-10-15DP
83478792028-07-15DP
80622642026-04-05DP
87525432026-04-05DP
93208622024-11-06DP
Fluticasone Propionate, Flovent Hfa, Glaxo Grp Ltd
75004442026-02-26DP
78323512023-06-19DP
Azelastine Hydrochloride / Fluticasone Propionate, Dymista, Mylan Speciality Lp
81686202026-02-24DP
81637232023-08-29U-77, U-81, U-644, U-707, U-1667
92594282023-06-13U-644
99015852023-06-13DP
ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD12: Fluticasone furoate
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK10: Vilanterol and fluticasone furoate
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL08: Vilanterol, umeclidinium bromide and fluticasone furoate
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BA: Glucocorticoid inhalants for obstructive airway disease
— R03BA09: Fluticasone furoate
HCPCS
No data
Clinical
Clinical Trials
595 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J453451787238272
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9910385522134
Allergic rhinitis seasonalD006255EFO_0003956J30—7179437
Allergic rhinitisD065631J30.953619336
Allergic rhinitis perennialD012221EFO_1001417J30.8911116322
Eosinophilic esophagitisD057765EFO_0004232K20.0—444212
Healthy volunteers/patients—5——2310
HypersensitivityD006967EFO_0003785T78.401—3217
Atopic dermatitisD003876EFO_0000274L20—115—7
Nasal polypsD009298HP_0100582J33112216
Show 17 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RhinitisD012220EFO_0008521J31——4—37
ConjunctivitisD003231H10——2——2
Gastrointestinal diseasesD005767—22——2
PolypsD011127EFO_0000662——1—12
Vasomotor rhinitisD012223EFO_0007533J30.0——2——2
Covid-19D000086382U07.1—12——2
Deglutition disordersD003680HP_0002015R13.1——1——1
Exercise-induced asthmaD001250J45.990——1——1
CroupD003440EFO_0007227J05.0——1——1
Allergic contact dermatitisD017449L23—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung diseasesD008171EFO_0003818J98.4—1——12
Bronchiolitis obliteransD001989EFO_0007183—1———1
BronchiectasisD001987HP_0002110J47—1———1
EsophagitisD004941HP_0100633K20—1———1
BlepharitisD001762EFO_0009536H01.0—1———1
EczemaD004485HP_0000964L30.9—1———1
PharmacokineticsD010599—1———1
BronchiolitisD001988HP_0011950—1———1
Bronchogenic carcinomaD002283—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138109————9
InflammationD0072491————1
Diabetes mellitusD003920EFO_0000400E08-E131————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiration disordersD012120J00-J99————22
SinusitisD012852EFO_0007486J32————11
Cystic fibrosisD003550EFO_0000390E84————11
VitiligoD014820EFO_0004208L80————11
SmokingD012907EFO_0003768F17————11
Medication adherenceD055118EFO_0006344————11
CognitionD003071EFO_0003925————11
Sleep wake disordersD012893G47————11
Bronchial hyperreactivityD016535————11
Only childD009863————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUTICASONE FUROATE
INNfluticasone furoate
Description
Fluticasone furoate is a trifluorinated corticosteroid that consists of 6alpha,9-difluoro-11beta,17alpha-dihydroxy-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-16-methyl-3-oxoandrosta-1,4-diene bearing a 2-furoyl substituent at position 17. Used in combination with vilanterol trifenate for treatment of bronchospasm associated with chronic obstructive pulmonary disease. It has a role as an anti-allergic agent, a prodrug and an anti-asthmatic drug. It is an 11beta-hydroxy steroid, a corticosteroid, a fluorinated steroid, a steroid ester, a 2-furoate ester, a thioester and a 3-oxo-Delta(1),Delta(4)-steroid. It is functionally related to a fluticasone. It derives from a hydride of an androstane.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(OC(=O)c1ccco1)C(=O)SCF
Identifiers
PDB—
CAS-ID397864-44-7
RxCUI705022
ChEMBL IDCHEMBL1676
ChEBI ID74899
PubChem CID9854489
DrugBankDB08906
UNII IDJS86977WNV (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xhance - OptiNose
$
€
£
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Trelegy ellipta - Innoviva, Inc.
$
€
£
₣
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Dymista - Viatris
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,287 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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42 adverse events reported
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