• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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 population* Efficacy 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
 
-
-