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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:  07/29/2005
 
Trade Name:  Avandia
 
Generic Name or Proper Name (*):  rosiglitazone
 
Indications Studied:  Type 2 Diabetes Mellitus
 
Label Changes Summary:  * Data are insufficient to recommend pediatric use of rosiglitazone * In a 24 week double-blind controlled trial in children with type 2 diabetes mellitus, aged 10 to 17 years, with a baseline BMI of 33 kg/m2 were randomized to treatment with rosiglitazone or metformin * Mean change from baseline in HbA1c was -0.14% with rosiglitazone and -0.49% with metformin * There was an insufficient number of patients to establish statistically whether these observed mean treatment effects were similar or different * Weight gain similar to that in adults * Information on PK parameters, and AE profile
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  SB Pharmco
 
Pediatric Exclusivity Granted Date:  12/09/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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