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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:
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
BPCA(B):
B
Sponsor:
SB Pharmco
Pediatric Exclusivity Granted Date:
12/09/2004
NNPS:
FALSE'
Therapeutic Category:
Antidiabetic
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