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Serevent, Aerivio spiromax(salmeterol)
Advair, Airduo, Serevent, Spiromax (salmeterol) is a small molecule pharmaceutical. Salmeterol was first approved as Serevent on 1994-02-04. It is used to treat asthma and bronchial spasm in the USA. It has been approved in Europe to treat asthma and chronic obstructive pulmonary disease. The pharmaceutical is active against beta-2 adrenergic receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Serevent
Combinations
Advair, Airduo (generic drugs available since 2019-01-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Salmeterol xinafoate
Tradename
Company
Number
Date
Products
SEREVENTGSKN-020692 RX1997-09-19
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
advair hfaNew Drug Application2021-08-25
airduo respiclickNew Drug Application2020-11-23
fluticasone propionate and salmeterolANDA2023-05-30
sereventNew Drug Application2020-01-13
wixela inhubANDA2023-03-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
bronchial spasm—D001986—
Agency Specific
FDA
EMA
Expiration
Code
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
Patent Expiration
Patent
Expires
Flag
FDA Information
Fluticasone Propionate / Salmeterol Xinafoate, Airduo 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
90669572034-10-06DPU-645
94150082034-10-06DPU-645
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
99872292024-09-01DP
75402822023-05-06DP
Fluticasone Propionate / Salmeterol Xinafoate, Advair Hfa, Glaxo Grp Ltd
75004442026-02-26DP
78323512023-06-19DP
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AC: Selective beta-2-adrenoreceptor agonist inhalants
— R03AC12: Salmeterol
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK06: Salmeterol and fluticasone
— R03AK12: Salmeterol and budesonide
HCPCS
No data
Clinical
Clinical Trials
309 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_0000270J451316444826147
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9716454919136
EmphysemaD004646EFO_0000464J43——2114
Chronic bronchitisD029481J42——2114
Bronchial spasmD001986———2—2
Disease progressionD018450———1—1
Allergic rhinitisD065631J30.9———1—1
DepressionD003863F33.9———1—1
Voice disordersD014832———1—1
Oral candidiasisD002180EFO_0007406B37.0———1—1
Show 1 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Exercise-induced asthmaD001250J45.990——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung diseasesD008171EFO_0003818J98.4—1——12
Obstructive lung diseasesD008173HP_0006536—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138107————7
Healthy volunteers/patients—7————7
Spinal cord injuriesD013119EFO_10019191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiration disordersD012120J00-J99————22
Allergic rhinitis seasonalD006255EFO_0003956J30————11
ObesityD009765EFO_0001073E66.9————11
Medication adherenceD055118EFO_0006344————11
Sleep wake disordersD012893G47————11
Cystic fibrosisD003550EFO_0000390E84————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSALMETEROL
INNsalmeterol
Description
2-(hydroxymethyl)-4-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)phenol is a phenol having a hydroxymethyl group at C-2 and a 1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl group at C-4; derivative of phenylethanolamine. It is a member of phenols, an ether, a secondary alcohol, a primary alcohol and a secondary amino compound. It is functionally related to a phenylethanolamine.
Classification
Small molecule
Drug classanti-inflammatory agents (salicylic acid derivatives); bronchodilators (phenethylamine derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Identifiers
PDB6MXT
CAS-ID89365-50-4
RxCUI36117
ChEMBL IDCHEMBL1263
ChEBI ID64064
PubChem CID5152
DrugBankDB00938
UNII ID2I4BC502BT (ChemIDplus, GSRS)
Target
Agency Approved
ADRB2
ADRB2
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
154
Protein name
beta-2 adrenergic receptor
Protein synonyms
adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor
Uniprot ID
Q9UMZ5
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Alternate
No data
Variants
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV000225937ADRB2, 46G>A, Gly16Argdrug response2021-03-242A
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 8,277 documents
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Safety
Black-box Warning
Black-box warning for: Serevent
Adverse Events
Top Adverse Reactions
Mock data
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11,935 adverse events reported
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