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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:  09/01/2004
 
Trade Name:  Clarinex
 
Generic Name or Proper Name (*):  desloratadine
 
Indications Studied:  Seasonal and perennial allergic rhinitis, and the symptomatic relief of pruritus, and hives
 
Label Changes Summary:  * Indicated for seasonal allergic rhinitis down to 2 years of age. Extended age range down to 6 months for perennial allergic rhinitis and chronic idiopathic urticaria * Safety and effectiveness of tablets or syrup has not been established in pediatric patients less than 6 months of age * Information on dose, PK parameters, and AE profile in pediatric patients 6 months - 11 years of age
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Schering
 
Pediatric Exclusivity Granted Date:  02/12/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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