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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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