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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:  12/15/2010
 
Trade Name:  Uroxatral
 
Generic Name or Proper Name (*):  alfuzosin
 
Indications Studied:  Elevated detrusor leak point pressure of neurologic origin
 
Label Changes Summary:  Uroxatral is not indicated for use in the pediatric populationEfficacy was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years using pediatric formulations
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Sanofi Aventis
 
Pediatric Exclusivity Granted Date:  09/07/2010
 
NNPS:  FALSE'
 
Therapeutic Category:  Urology
 
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