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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
Therapeutic Category:  Antiviral