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Drug ReportsSalmeterol
Salmeterol
Advair, Airduo, Fluticasone / Salmeterol Xinafoate, Serevent, Spiromax, Wixela (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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Events Timeline
Commercial
Clinical
Drug
Target
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Financial
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Safety
Events Timeline
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
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
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 salmeterolANDA2024-12-05
fluticasone propionate and salmeterol hfaNDA authorized generic2024-05-29
sereventNew Drug Application2022-10-10
wixela inhubANDA2022-08-29
Indications
FDA
EMA
No data
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
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)Loading
Structure (InChI/SMILES or Protein Sequence)
OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Identifiers
PDB—
CAS-ID89365-50-4
RxCUI—
ChEMBL IDCHEMBL1263
ChEBI ID64064
PubChem CID5152
DrugBankDB00938
UNII ID2I4BC502BT (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Salmeterol
+
Fluticasone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Salmeterol
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Tabular view
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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