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Drug ReportsSalmeterol xinafoate
Serevent, Airexar spiromax(salmeterol xinafoate)
Advair, Airduo, Fluticasone / Salmeterol Xinafoate, Serevent, Spiromax, Wixela (salmeterol xinafoate) is a small molecule pharmaceutical. Salmeterol xinafoate 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.
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5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
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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 (discontinued: Serevent)
Combinations
Advair, Airduo, Fluticasone salmeterol xinafoate, Wixela (discontinued: Airduo)
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 RESPICLICKTevaN-208799 RX2017-01-27
3 products, RLD, RS
Show 1 discontinued
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
advairNew Drug Application2023-06-30
advair diskusNew Drug Application2024-01-30
advair hfaNew Drug Application2024-05-23
airduo digihalerNew Drug Application2024-04-29
airduo respiclickNew Drug Application2024-02-06
fluticasone propionate and salmeterol hfaNDA authorized generic2024-05-29
sereventNew Drug Application2022-10-10
wixela inhubANDA2022-08-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
allergic rhinitis perennialEFO_1001417D012221J30.89
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
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
424 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_0000270J452154—12
Lung diseasesD008171HP_0002088J98.4———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSalmeterol xinafoate
INN—
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)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(O)c1ccc2ccccc2c1O.OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Identifiers
PDB—
CAS-ID89365-50-4
RxCUI36117
ChEMBL IDCHEMBL1082607
ChEBI ID—
PubChem CID5152
DrugBankDB00938
UNII ID—
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,236 documents
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Safety
Black-box Warning
Black-box warning for: Serevent
Adverse Events
Top Adverse Reactions
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75,453 adverse events reported
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