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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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