vilanterol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
bronchodilators, phenethylamine derivatives 4799 503068-34-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • GW642444X
  • vilanterol
  • Breo Ellipta
  • vilanterol trifenatate
  • GW642444M
Vilanterol is a long-acting beta2-adrenergic agonist. The clinical relevance of this in vitro finding is unknown. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
  • Molecular weight: 486.43
  • Formula: C24H33Cl2NO5
  • CLOGP: 3.19
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 91.18
  • ALOGS: -5.61
  • ROTB: 16

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 2.38 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 25.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 10, 2013 FDA GLAXO GRP LTD

FDA Adverse Event Reporting System (Female)

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
Asthma 673.36 47.99 128 308 11186 2346463
Dyspnoea 360.06 47.99 113 323 78620 2279029
Obstructive airways disorder 353.44 47.99 55 381 1318 2356331
Wheezing 257.15 47.99 53 383 6331 2351318
Cough 227.68 47.99 66 370 33051 2324598
Blood count abnormal 190.48 47.99 35 401 2247 2355402
Therapeutic product effect incomplete 167.41 47.99 41 395 10490 2347159
Respiratory symptom 160.02 47.99 22 414 204 2357445
Dyspnoea exertional 152.85 47.99 34 402 5686 2351963
Nasal polyps 144.42 47.99 20 416 196 2357453
Chest discomfort 130.47 47.99 36 400 14559 2343090
Productive cough 116.91 47.99 27 409 5294 2352355
Chronic obstructive pulmonary disease 114.34 47.99 28 408 7049 2350600
Candida infection 109.92 47.99 23 413 2850 2354799
Drug ineffective 100.22 47.99 49 387 101575 2256074
Sputum increased 98.63 47.99 14 422 165 2357484
Salpingo-oophorectomy unilateral 97.37 47.99 11 425 12 2357637
Chronic sinusitis 96.52 47.99 16 420 549 2357100
Lower respiratory tract infection 90.23 47.99 22 414 5402 2352247
Embolism venous 89.62 47.99 14 422 327 2357322
Female genital tract fistula 84.63 47.99 14 422 473 2357176
Hiatus hernia 81.45 47.99 17 419 2067 2355582
Diastolic dysfunction 80.81 47.99 14 422 626 2357023
Sinusitis fungal 80.57 47.99 11 425 95 2357554
Emphysema 79.72 47.99 15 421 1070 2356579
Gastrooesophageal reflux disease 78.94 47.99 22 414 9073 2348576
Osteoporosis 73.83 47.99 18 418 4396 2353253
Weight increased 70.82 47.99 25 411 22312 2335337
Diverticulum 69.10 47.99 14 422 1465 2356184
Tricuspid valve incompetence 67.52 47.99 14 422 1642 2356007
Dysphonia 67.30 47.99 18 418 6346 2351303
Iron deficiency anaemia 64.22 47.99 14 422 2085 2355564
Sleep apnoea syndrome 64.04 47.99 14 422 2112 2355537
Eczema 63.53 47.99 15 421 3190 2354459
Disease recurrence 62.43 47.99 15 421 3436 2354213
Osteoarthritis 61.10 47.99 17 419 6929 2350720
Oedema peripheral 58.17 47.99 22 414 23741 2333908
Fungal infection 57.24 47.99 15 421 4874 2352775
Hypertension 55.16 47.99 22 414 27339 2330310
Eosinophil count increased 54.52 47.99 11 425 1123 2356526
Condition aggravated 51.84 47.99 22 414 31957 2325692
Pneumonia 51.68 47.99 25 411 49271 2308378
Sinusitis 50.37 47.99 18 418 16508 2341141
Hysterectomy 50.35 47.99 11 425 1649 2356000

FDA Adverse Event Reporting System (Male)

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
Asthma 315.45 69.34 62 267 4842 1741610
Dyspnoea 201.44 69.34 70 259 51989 1694463
Obstructive airways disorder 167.92 69.34 29 300 1045 1745407
Therapeutic product effect incomplete 126.19 69.34 30 299 5418 1741034
Chronic obstructive pulmonary disease 123.54 69.34 30 299 5923 1740529
Cough 121.80 69.34 38 291 19159 1727293
Blood count abnormal 120.63 69.34 23 306 1434 1745018
Wheezing 91.41 69.34 22 307 4131 1742321
Sputum discoloured 90.19 69.34 16 313 661 1745791
Foetal malformation 82.08 69.34 10 319 22 1746430
Trisomy 18 78.24 69.34 10 319 37 1746415
Drug ineffective 74.39 69.34 37 292 63764 1682688
Pneumonia 72.73 69.34 33 296 46149 1700303

Pharmacologic Action:

SourceCodeDescription
ATC R03AK10 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL03 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
CHEBI has role CHEBI:35522 beta-adrenergic agonist
CHEBI has role CHEBI:35523 bronchodilator agent
FDA MoA N0000009922 Adrenergic beta2-Agonists
FDA EPC N0000175779 beta2-Adrenergic Agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic obstructive lung disease indication 13645005 DOID:3083
Chronic bronchitis indication 63480004 DOID:6132
Pulmonary emphysema indication 87433001
Asthma indication 195967001 DOID:2841

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.07 acidic
pKa2 9.28 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION RE44874 March 23, 2023 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 8309572 April 27, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
EQ 0.025MG BASE/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 UMECLIDINIUM, VIA TOPICAL APPLICATION
EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 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 CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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
EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 8183257 July 27, 2025 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
EQ 0.025MG BASE/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 UMECLIDINIUM, VIA INHALATION
EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION 8511304 June 14, 2027 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
EQ 0.025MG BASE/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
EQ 0.025MG BASE/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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.025MG BASE/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.
EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION April 24, 2021 REVISED INDICATION FOR FIXED-DOSE COMBINATION OF FLUTICASONE FUROATE, UMECLIDINIUM, AND VILANTEROL TO TREAT AIRFLOW OBSTRUCTION IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND TO REDUCE COPD EXACERBATIONS IN PTS WITH HISTORY OF EXACERBATIONS
EQ 0.025MG BASE/INH ANORO ELLIPTA GLAXOSMITHKLINE N203975 Dec. 18, 2013 RX POWDER INHALATION June 9, 2022 ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-2 adrenergic receptor GPCR AGONIST EC50 9.40 WOMBAT-PK CHEMBL
Beta-3 adrenergic receptor GPCR EC50 6.10 WOMBAT-PK
Beta-1 adrenergic receptor GPCR EC50 6.40 WOMBAT-PK

External reference:

IDSource
D09696 KEGG_DRUG
4032565 VUID
N0000188266 NUI
C2935023 UMLSCUI
028LZY775B UNII
9198 INN_ID
503070-58-4 SECONDARY_CAS_RN
C550468 MESH_SUPPLEMENTAL_RECORD_UI
CHEMBL1084647 ChEMBL_ID
CHEMBL1084172 ChEMBL_ID
CHEMBL1198857 ChEMBL_ID
DB09082 DRUGBANK_ID
CHEBI:75037 CHEBI
10184665 PUBCHEM_CID
7353 IUPHAR_LIGAND_ID
720194004 SNOMEDCT_US
1424884 RXNORM
015022 NDDF
29456 MMSL
d08099 MMSL
4032565 VANDF
702408004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0859 POWDER 25 ug RESPIRATORY (INHALATION) NDA 19 sections
Anoro Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0869 POWDER 25 ug RESPIRATORY (INHALATION) NDA 18 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0882 POWDER 25 ug RESPIRATORY (INHALATION) NDA 19 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0887 POWDER 25 ug RESPIRATORY (INHALATION) NDA 18 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 70518-2028 POWDER 25 ug RESPIRATORY (INHALATION) NDA 19 sections