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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  10/16/2006
 
Trade Name:  Allegra
 
Generic Name or Proper Name (*):  fexofenadine
 
Indications Studied:  Seasonal allergic rhinitis (SAR) uncomplicated skin manifestations of chronic idiopathic urticaria (CIU)
 
Label Changes Summary:  * New suspension developed * Suspension indicated for the treatment of SAR in 2  11 years based on the PK comparisons in adult and pediatric patients and an extrapolation of efficacy in adults; Suspension indicated for the treatment of CIU in 6 months  11 years based on the PK comparisons in adults and children and an extrapolation of efficacy in adults * Safety and effectiveness of suspension in pediatric patients under 6 months of age have not been established * Additional information on dose, PK parameters, safety and AEs
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Aventis
 
Pediatric Exclusivity Granted Date:  01/27/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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