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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:  12/20/2013
 
Trade Name:  Isentress
 
Generic Name or Proper Name (*):  raltegravir
 
Indications Studied:  HIV-1 infection
 
Label Changes Summary:  *Packet for oral suspension: Approved for use in infants 4 weeks and older, weighing at least 3 kg to < 20 kg. Chewable tablet previously approved down to 2 years* Safety and dosing information have not been established in infants less than 4 weeks *Adverse reactions similar to those observed in adults* Information on dosing,clinical trial and PK parameters*Information on preparation of a suspension*New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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