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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:  10/03/2019
Trade Name:  Tybost
Generic Name or Proper Name (*):  cobicistat
Indications Studied:  Co-administered with darunavir for treatment of HIV-1 infection in pediatric patients weighing at least 35 kg
Label Changes Summary:  *Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial in virologically suppressed, HIV-1 infected pediatric patients aged 12 years and older. *The safety in these patients through 48 weeks was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in combination with darunavir in pediatric patients weighing less than 40 kg have not been established. • Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, clinical trial. *Postmarketing study.
BPCA(B) and PREA(P):  B,P
Sponsor:  Gilead Sciences
Therapeutic Category:  Antiviral