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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
Therapeutic Category:  Antiviral