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Drug ReportsLevocetirizine
Levocetirizine
Levocetirizine, Xyzal (levocetirizine) is a small molecule pharmaceutical. Levocetirizine was first approved as Xyzal on 2007-05-25. It is used to treat allergic rhinitis perennial, allergic rhinitis seasonal, and urticaria in the USA. The pharmaceutical is active against histamine H1 receptor.
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Target
Variants
Financial
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Events Timeline
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Levocetirizine, Xyzal (discontinued: Levocetirizine, Xyzal)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levocetirizine dihydrochloride
Tradename
Company
Number
Date
Products
XYZAL ALLERGY 24HRSanofiN-209089 OTC2017-01-31
1 products, RLD, RS
XYZAL ALLERGY 24HRSanofiN-209090 OTC2017-01-31
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
12 hour allergy dANDA2020-09-03
24 hour allergyNew Drug Application2024-04-01
24hr allergy reliefANDA2024-10-22
all dayANDA2020-06-18
all day allergyANDA2025-04-07
all day allergy dANDA2025-02-12
all day allergy reliefANDA2024-12-20
all day allergy relief dANDA2018-12-06
allergyANDA2024-06-03
allergy and congestion relief dANDA2023-05-30
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis seasonalEFO_0003956D006255J30
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Levocetirizine Dihydrochloride, Xyzal Allergy 24hr, Chattem Sanofi
86331942027-10-16DP
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AE: Piperazine derivatives, systemic antihistamines
— R06AE09: Levocetirizine
HCPCS
No data
Clinical
Clinical Trials
78 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FastingD005215EFO_0002756—1————1
MalnutritionD044342EFO_0008572E40-E461————1
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLevocetirizine
INNlevocetirizine
Description
2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxy]acetic acid is a diarylmethane.
Classification
Small molecule
Drug classSecond generation antihistamines
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)COCCN1CCN([C@H](c2ccccc2)c2ccc(Cl)cc2)CC1
Identifiers
PDB—
CAS-ID130018-77-8
RxCUI—
ChEMBL IDCHEMBL1201191
ChEBI ID—
PubChem CID1549000
DrugBankDB06282
UNII ID6U5EA9RT2O (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Levocetirizine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,094 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,343 adverse events reported
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