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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:  03/15/2004
 
Trade Name:  Glucovance
 
Generic Name or Proper Name (*):  glyburide/ metformin
 
Indications Studied:  Type 2 Diabetes Mellitus
 
Label Changes Summary:  As studied in active-controlled, double blind trial in pediatric patients (9  16 years of age), Glucovance was not statistically superior to either metformin or glyburide in reducing HbA1C from baseline No unexpected safety findings
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Bristol-Myers Squibb
 
Pediatric Exclusivity Granted Date:  10/08/2003
 
NNPS:  FALSE'
 
Therapeutic Category:  Antidiabetic
 
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