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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:  11/22/2017
 
Trade Name:  Isentress oral suspension
 
Generic Name or Proper Name (*):  raltegravir
 
Indications Studied:  HIV exposed neonates ages 0-4 weeks and weighing at least 2 kg
 
Label Changes Summary:  *Safety and pharmacokinetics of Isentress oral suspension were evaluated in 42 full-term HIV-1 exposed neonates at high risk of acquiring HIV-1 infection in a Phase 1, open-label, multicenter clinical study. *Not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg. *Safety profile was similar to that observed in adults. *Postmarketing study.
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
Pediatric Exclusivity Granted Date:  08/14/2017
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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