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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:
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
BPCA(B):
B
Sponsor:
Sanofi Aventis
Pediatric Exclusivity Granted Date:
09/07/2010
NNPS:
FALSE'
Therapeutic Category:
Urology
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