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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Aventis
Pediatric Exclusivity Granted Date:
01/27/2003
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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