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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:  05/26/2017
 
Trade Name:  Isentress HD
 
Generic Name or Proper Name (*):  raltegravir
 
Indications Studied:  In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and in pediatric patients weighing at least 40 kg
 
Label Changes Summary:  *New 600 mg film coated tablet approved for once daily use. *Isentress HD once daily has not been studied in pediatric patients. However population PK modeling and simulation support the use of 1200 mg (2 x 600 mg) once daily in pediatric patients weighing at least 40 kg. *New dosage form.
 
PREA(P):  P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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