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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:  09/24/2015
 
Trade Name:  Reyataz Oral Powder
 
Generic Name or Proper Name (*):  atazanavir
 
Indications Studied:  HIV-1
 
Label Changes Summary:  *Expanded indication to patients 3 months and older weighing 5 to < 10 kg and to those weighing > 25 kg; previously approved in patients 3 months of age and older weighing at least 10 kg. *Not recommended for patients weighing less than 5 kg. *Information on PK, dosing and clinical trial. *Postmarketing study
 
BPCA(B) and PREA(P):  B, P
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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