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Fexofenadine

Generic Name
Fexofenadine
Brand Names
Allegra, Allegra-D, Mucinex Non-drowsy Allergy, Wal-fex, Telfast
Drug Type
Small Molecule
Chemical Formula
C32H39NO4
CAS Number
83799-24-0
Unique Ingredient Identifier
E6582LOH6V

Overview

Fexofenadine is an over-the-counter second-generation antihistamine used in the treatment of various allergic symptoms. It is selective for the H receptor, carries little-to-no activity at off-targets, and does not cross the blood-brain barrier - this is in contrast to previous first-generation antihistamines, such as diphenhydramine, which readily bind to off-targets that contribute to side effects such as sedation. Fexofenadine is the major active metabolite of terfenadine and is administered as a racemic mixture in which both enantiomers display approximately equivalent antihistamine activity.

Indication

In the United States, fexofenadine is indicated for the symptomatic treatment of allergic rhinitis in patients ≥2 years old and chronic idiopathic urticaria in patients ≥6 months old. In Canada, fexofenadine carries the same indications but is approved only for patients ≥12 years old. Fexofenadine is also available in combination with pseudoephedrine for the symptomatic treatment of season allergic rhinitis in patients ≥12 years old.

Associated Conditions

  • Allergic Rhinitis (AR)
  • Chronic Idiopathic Urticaria
  • Seasonal Allergic Rhinitis

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2012/02/03
Not Applicable
Completed
2011/11/10
Phase 4
Completed
2011/03/02
Phase 3
Completed
2010/10/26
Phase 3
Completed
2010/07/29
Phase 2
Completed
The Connecticut Sinus Center, PC
2010/05/28
Phase 1
Completed
2010/05/28
Phase 1
Completed
2010/02/10
Phase 1
Completed
2010/02/10
Phase 1
Completed
2009/12/16
Phase 2
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
PHARMACY HEALTH FEXOFENADINE HAYFEVER & ALLERGY RELIEF fexofenadine hydrochloride 180 mg film coated tablet blister pack (new formulation)
410635
Medicine
A
6/15/2023
FEXAREN 180 fexofenadine hydrochloride 180 mg film coated tablet blister pack
462001
Medicine
A
9/5/2024
FEXOFENADINE-DRLA fexofenadine hydrochloride 180 mg film coated tablet blister pack
182787
Medicine
A
5/2/2011
AVALLON FEXOFENADINE HAYFEVER ALLERGY RELIEF fexofenadine hydrochloride 120 mg film coated tablet blister pack
388429
Medicine
A
5/13/2022
COLES HAYFEVER ALLERGY RELIEF FEXOFENADINE HYDROCHLORIDE 180mg tablet blister pack
446090
Medicine
A
4/22/2024
FEXACLEAR fexofenadine hydrochloride 120 mg film-coated tablet blister pack
463372
Medicine
A
9/30/2024
AMCAL FEXOFENADINE HAYFEVER & ALLERGY RELIEF 180 mg film coated tablet blister pack
462164
Medicine
A
9/11/2024
TELFAST 6-11 YEARS fexofenadine hydrochloride 30mg tablet blister pack
75139
Medicine
A
7/10/2000
APO-FEXOFENADINE 120 HAYFEVER ALLERGY RELIEF fexofenadine hydrochloride 120mg film coated tablet blister pack
270817
Medicine
A
2/19/2016
PHARMACY CHOICE FEXO 180 fexofenadine hydrochloride 180mg film coated tablet blister pack
207486
Medicine
A
3/26/2013

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