fluticasone furoate indications/contra

Stem definitionDrug idCAS RN
4554 397864-44-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluticasone furoate
  • avamys
  • veramyst
Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti‑inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.
  • Molecular weight: 538.58
  • Formula: C27H29F3O6S
  • CLOGP: 4.26
  • LIPINSKI: 1
  • HAC: 6
  • HDO: 1
  • TPSA: 93.81
  • ALOGS: -4.09
  • ROTB: 6

Drug dosage:

DoseUnitRoute
0.20 mg N
0.11 mg N
0.60 mg Inhal.aerosol
0.60 mg Inhal.powder
1.50 mg Inhal.solution

Approvals:

DateAgencyCompanyOrphan
April 27, 2007 FDA GLAXOSMITHKLINE

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 175.96 34.04 77 622 102857 3282303
Epistaxis 141.57 34.04 40 659 14411 3370749
Asthma 138.26 34.04 38 661 12364 3372796
Anosmia 120.39 34.04 22 677 1103 3384057
Chronic obstructive pulmonary disease 114.62 34.04 32 667 10977 3374183
Drug ineffective 92.58 34.04 52 647 116038 3269122
Dysphonia 88.10 34.04 24 675 7480 3377680
Pneumonia 71.20 34.04 37 662 70106 3315054
Cough 61.34 34.04 28 671 39830 3345330
Wheezing 59.36 34.04 18 681 8153 3377007
Product quality issue 58.18 34.04 24 675 26711 3358449
Candida infection 43.76 34.04 12 687 3800 3381360
Chorioretinopathy 41.72 34.04 8 691 516 3384644
Dizziness 41.67 34.04 27 672 76485 3308675
Mycobacterium avium complex infection 41.13 34.04 8 691 556 3384604
Throat irritation 39.86 34.04 12 687 5282 3379878
Cortisol decreased 38.06 34.04 7 692 360 3384800

Pharmacologic Action:

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SourceCodeDescription
ATC R01AD12 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03BA09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
ATC R03AK10 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
ATC D07AC17 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC R01AD08 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R01AD58 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03BA05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
FDA EPC N0000175576 Corticosteroid
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D001337 Autonomic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:49167 anti-asthmatic drug

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Asthma indication 195967001 DOID:2841
Chronic Non-Allergic Rhinitis indication
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Epistaxis contraindication 12441001
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Viral disease contraindication 34014006 DOID:934
Hypercortisolism contraindication 47270006 DOID:3947
Perforation of nasal septum contraindication 80142000
Bacterial infectious disease contraindication 87628006 DOID:104
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Pulmonary tuberculosis contraindication 154283005 DOID:2957
Ophthalmic herpes simplex contraindication 186542001
Varicella-zoster virus infection contraindication 309465005
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Exposure to varicella contraindication 444453009
Nasal Candidiasis contraindication
Nasal Septal Ulcers contraindication
Nasal Trauma contraindication

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.49 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.0275MG/SPRAY FLONASE SENSIMIST ALLERGY RELIEF GLAXOSMITHKLINE CONS N022051 Aug. 2, 2016 OTC SPRAY, METERED NASAL 6858596 Aug. 3, 2021 OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES; NASAL CONGESTION, RUNNY NOSE, SNEEZING, ITCHY NOSE, AND (ITCHY WATER EYES (AGES 12 AND UP))
0.0275MG/SPRAY FLONASE SENSIMIST ALLERGY RELIEF GLAXOSMITHKLINE CONS N022051 Aug. 2, 2016 OTC SPRAY, METERED NASAL 7101866 Aug. 3, 2021 OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES; NASAL CONGESTION, RUNNY NOSE, SNEEZING, ITCHY NOSE, AND (ITCHY WATER EYES (AGES 12 AND UP))
0.0275MG/SPRAY FLONASE SENSIMIST ALLERGY RELIEF GLAXOSMITHKLINE CONS N022051 Aug. 2, 2016 OTC SPRAY, METERED NASAL 7541350 Aug. 3, 2021 OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES; NASAL CONGESTION, RUNNY NOSE, SNEEZING, ITCHY NOSE, AND (ITCHY WATER EYES (AGES 12 AND UP))
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 6537983 Aug. 3, 2021 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 6537983 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 6759398 Aug. 3, 2021 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 6759398 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 6878698 Aug. 3, 2021 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 7101866 Aug. 3, 2021 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 7101866 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 6537983 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 6759398 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 7101866 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH ARNUITY ELLIPTA GLAXOSMITHKLINE N205625 Aug. 20, 2014 RX POWDER INHALATION 7101866 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER
0.2MG/INH ARNUITY ELLIPTA GLAXOSMITHKLINE N205625 Aug. 20, 2014 RX POWDER INHALATION 7101866 Aug. 3, 2021 INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 6537983 Aug. 3, 2021 THE TREATMENT OF AN INFLAMMATORY DISORDER OF THE RESPIRATORY TRACT BY ONCE-PER-DAY ADMINISTRATION OF A PHARMACEUTICAL FORMULATION COMPRISING FLUTICASONE FUROATE AND A LONG-ACTING BETA2 ADRENORECEPTOR AGONIST
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 6759398 Aug. 3, 2021 THE TREATMENT OF AN INFLAMMATORY DISORDER OF THE RESPIRATORY TRACT BY ONCE-PER-DAY ADMINISTRATION OF A PHARMACEUTICAL FORMULATION COMPRISING FLUTICASONE FUROATE AND A LONG-ACTING BETA2 ADRENORECEPTOR AGONIST
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 6878698 Aug. 3, 2021 THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE BY ONCE-PER-DAY ADMINISTRATION OF A PHARMACEUTICAL FORMULATION COMPRISING FLUTICASONE FUROATE AND A LONG-ACTING BETA2 ADRENORECEPTOR
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 7101866 Aug. 3, 2021 USE OF FLUTICASONE FUROATE FOR THE TREATMENT OF AN INFLAMMATORY OR ALLERGIC CONDITIONS, INCLUDING CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION RE44874 March 23, 2023 FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 8309572 April 27, 2025 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLININUM, VIA TOPICAL APPLICATION
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 7439393 May 21, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 8183257 July 27, 2025 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLININUM, VIA INHALATION
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 8511304 June 14, 2027 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 8511304 June 14, 2027 LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 8511304 June 14, 2027 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION April 30, 2018 DAILY TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION April 30, 2018 NEW PRODUCT
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION May 10, 2018 NEW CHEMICAL ENTITY
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION May 10, 2018 NEW CHEMICAL ENTITY
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION May 10, 2018 NEW CHEMICAL ENTITY
0.1MG/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION Dec. 18, 2018 NEW CHEMICAL ENTITY
0.1MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION May 15, 2020 INCLUSION OF DATA FROM THE SUMMIT STUDY FOR BREO ELLIPTA (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE) INHALATION POWDER IN THE PACKAGE INSERT.
0.2MG/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION May 15, 2020 INCLUSION OF DATA FROM THE SUMMIT STUDY FOR BREO ELLIPTA (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE) INHALATION POWDER IN THE PACKAGE INSERT.

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST IC50 10.12 CHEMBL CHEMBL
Glucocorticoid receptor Transcription factor IC50 8.30 CHEMBL

External reference:

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IDSource
D06315 KEGG_DRUG
4026165 VUID
N0000179800 NUI
C1948374 UMLSCUI
CHEMBL1473 ChEMBL_ID
CHEMBL1676 ChEMBL_ID
CHEMBL1201396 ChEMBL_ID
C523187 MESH_SUPPLEMENTAL_RECORD_UI
DB08906 DRUGBANK_ID
JS86977WNV UNII
8521 INN_ID
23848 MMSL
4026165 VANDF
426409006 SNOMEDCT_US
705022 RXNORM
N0000176104 NDFRT
N0000179800 NDFRT
012173 NDDF
9854489 PUBCHEM_CID
CHEBI:74899 CHEBI
GW6 PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
FLONASE SENSIMIST HUMAN OTC DRUG LABEL 1 0135-0615 SPRAY, METERED 27.50 ug NASAL NDA 9 sections
FLONASE SENSIMIST HUMAN OTC DRUG LABEL 1 0135-0616 SPRAY, METERED 27.50 ug NASAL NDA 9 sections
VERAMYST HUMAN PRESCRIPTION DRUG LABEL 1 0173-0753 SPRAY, METERED 27.50 ug NASAL NDA 17 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0859 POWDER 100 ug RESPIRATORY (INHALATION) NDA 19 sections
Arnuity Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 0173-0874 POWDER 100 ug RESPIRATORY (INHALATION) NDA 17 sections
Arnuity Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 0173-0876 POWDER 200 ug RESPIRATORY (INHALATION) NDA 17 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0882 POWDER 200 ug RESPIRATORY (INHALATION) NDA 19 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0887 POWDER 100 ug RESPIRATORY (INHALATION) NDA 18 sections
Veramyst HUMAN PRESCRIPTION DRUG LABEL 1 54868-6168 SPRAY, METERED 27.50 ug NASAL NDA 18 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 63379-017 POWDER 100 ug RESPIRATORY (INHALATION) Approved Drug Product Manufactured Under Contract 1 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 63379-059 POWDER 200 ug RESPIRATORY (INHALATION) Approved Drug Product Manufactured Under Contract 1 sections