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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:  06/02/2014
 
Trade Name:  Reyataz
 
Generic Name or Proper Name (*):  atazanavir
 
Indications Studied:  Treatment of HIV - 1 infection
 
Label Changes Summary:  Reyataz oral powder approved for use in pediatric patients at least 3 months and between 10 kg to less than 25 kg; capsule previously approved in 6 years and olderNot recommended in pediatric patients less than 3 months because of the risk of kernicterusReyataz oral powder contains phenylalanine which can be harmful to patients with phenylketonuria Adverse reactions were similar to those observed in adultsOral powder must be mixed with food or beverage for administration and ritonavir must be given immediately afterwards Information on mixing oral powder with food such as appleasauce or yogurt or milk, water or infant formula Information on dosing in patients at least 3 months and weighing between 10 to less than 25kg, adverse reactions, laboratory abnormalities, PK parameters, and clinical trialsNew dosage form
 
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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