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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:  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  Opens a new window
 
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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