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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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