Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-