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Drug ReportsKetotifen fumarate
Ketotifen fumarate
Alaway, Ketotifen, Zaditor (ketotifen fumarate) is a small molecule pharmaceutical. Ketotifen fumarate was first approved as Ketotifen fumarate on 2006-05-09. It is used to treat allergic conjunctivitis in the USA.
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Therapeutic Area
MeSH
eye diseasesD005128
immune system diseasesD007154
Trade Name
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
acuvue theravision with ketotifenNew Drug Application2022-03-11
alawayNew Drug Application2022-05-01
allergy eye dropsANDA2022-01-25
equate eye itch reliefNew Drug Application2021-03-23
eye itchANDA2022-02-10
eye itch releifNew Drug Application2024-07-22
eye itch reliefNew Drug Application2024-10-01
good neighbor pharmacy eye itch reliefANDA2013-07-18
itchy eyeANDA2022-02-11
ketotifen fumarateANDA2024-07-12
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration
Code
KETOTIFEN FUMARATE, ACUVUE THERAVISION WITH KETOTIFEN, JOHNSON JOHNSON VISN
2025-02-25NP
Patent Expiration
Patent
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FDA Information
Ketotifen Fumarate, Acuvue Theravision With Ketotifen, Johnson Johnson Visn
99623762030-06-27DP
94747462028-03-27DP
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AX: Other antihistamines for systemic use in atc
— R06AX17: Ketotifen
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GX: Other antiallergics in atc
— S01GX08: Ketotifen
HCPCS
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Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConjunctivitisD003231HP_0000509H101——1—2
Allergic conjunctivitisD003233EFO_0007141H10.441——1—2
Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameKetotifen fumarate
INNketotifen
Description
Ketotifen is an organic heterotricyclic compound that is 4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one which is substituted at position 4 by a 1-methylpiperidin-4-ylidene group. A blocker of histamine H1 receptors with a stabilising action on mast cells, it is used (usually as its hydrogen fumarate salt) for the treatment of asthma, where it may take several weeks to exert its full effect. It has a role as a H1-receptor antagonist and an anti-asthmatic drug. It is an organosulfur heterocyclic compound, an organic heterotricyclic compound, a cyclic ketone, a member of piperidines, an olefinic compound and a tertiary amino compound. It is a conjugate base of a ketotifen(1+).
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
CN1CCC(=C2c3ccccc3CC(=O)c3sccc32)CC1.O=C(O)/C=C/C(=O)O
Identifiers
PDB—
CAS-ID34580-13-7
RxCUI6146
ChEMBL IDCHEMBL1633
ChEBI ID—
PubChem CID3827
DrugBankDB00920
UNII IDX49220T18G (ChemIDplus, GSRS)
Target
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PubMed Central
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Safety
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5,799 adverse events reported
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