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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:  12/16/2011
 
Trade Name:  Prezista
 
Generic Name or Proper Name (*):  darunavir
 
Indications Studied:  Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg
 
Label Changes Summary:  * Expanded indication to pediatric patients 3 years and older weighing at least 10 kg; previously approved for use in 6 years and older* Do not use in pediatric patients < 3 years of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* New formulation
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Tibotec
 
Pediatric Exclusivity Granted Date:  06/07/2011
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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