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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:  03/25/2008
 
Trade Name:  Reyataz
 
Generic Name or Proper Name (*):  atazanavir
 
Indications Studied:  HIV in 6 years and older
 
Label Changes Summary:  Extended indication from adults to children 6 years and older The safety, activity, and pharmacokinetic profiles in pediatric patients ages 3 months to < 6 years have not been established. Atazanavir should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus Dosing is based on body weight or body surface area not to exceed adult dose Adverse events (AEs) are generally similar to those seen in adults Information on dose, AEs, PK parameters, lab abnormalities, and clinical study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Bristol-Myers Squibb
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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