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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:  12/18/2008
Trade Name:  Prezista
Generic Name or Proper Name (*):  darunavir
Indications Studied:  Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents
Label Changes Summary:  * Extended indication from adults to pediatric patients 6 years and older * Safety and effectiveness in pediatric patients 3 to < 6 years of age have not been established * Do not administer in pediatric patients below 3 years of age * Do not administer Prezista/rtv once daily in pediatric patients * Dosing for patients 6 to < 18 years and weighing at least 44 lbs (20 kg) is based on body weight not to exceed adult dose * AE 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:  Tibotec
Pediatric Exclusivity Granted Date:  06/07/2011
Therapeutic Category:  Antiviral