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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:
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
BPCA(B):
B
Sponsor:
Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:
10/08/2003
NNPS:
FALSE'
Therapeutic Category:
Antidiabetic
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