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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:  12/22/2009
 
Trade Name:  Flomax
 
Generic Name or Proper Name (*):  tamsulosin
 
Indications Studied:  Treatment of elevated detrusor leak point pressure associated with neurological disorder
 
Label Changes Summary:  * Efficacy and positive benefit/risk was not demonstrated in 2 studies (a randomized, double-blind, safety and efficacy study and an open label safety study) conducted in patients 2 -16 years * The most frequently reported adverse events from the 2 studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. * Information added to Pediatric Use
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Boehringer Ingelheim
 
Pediatric Exclusivity Granted Date:  09/17/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Urology
 
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