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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:  11/30/2012
 
Trade Name:  Invirase
 
Generic Name or Proper Name (*):  saquinavir
 
Indications Studied:  Treatment of HIV infection in combination with ritonavir
 
Label Changes Summary:  *The safety and activity of saquinavir have been evaluated in 68 pediatric patients 4 months -< 16 years treated with Invirase boosted with either ritonavir or with lopinavir/ritonavir in 2 clinical trials. * Steady state saquinavir exposures observed in pediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed. Pediatric dose recommendations that are both reliably effective and below thresholds of concern with respect to QT and PR prolongation could not be determined. * Information on clinical studies, and pharmacokinetics
 
Product Labeling:  urlLabeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Hoffman- LaRoche
 
Pediatric Exclusivity Granted Date:  10/26/2010
 
NNPS:  False
 
Therapeutic Category:  Antiviral
 
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