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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:
11/28/2005
Trade Name:
Amaryl
Generic Name or Proper Name (*):
glimepiride
Indications Studied:
Type-2 Diabetes Mellitus
Label Changes Summary:
Data are insufficient to recommend pediatric use of glimepiride In an active-controlled, single-blind, 24-week trial, 272 pediatric patients aged 8 to 17 years with Type 2 diabetes were randomized to treatment with glimepiride or metformin. Trial suggested differences favoring metformin AE profile in the pediatric population was similar to that for adults Information on PK parameters
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Aventis
Pediatric Exclusivity Granted Date:
06/09/2005
NNPS:
FALSE'
Therapeutic Category:
Antidiabetic
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