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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:  03/22/2018
 
Trade Name:  Symfi
 
Generic Name or Proper Name (*):  efavirenz, lamivudine and tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of HIV-1 infection in adult and pediatric patients weighing at least 40 kg
 
Label Changes Summary:  *Safety and effectiveness of Symfi as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 40 kg have been established based on clinical studies using the individual components (efavirenz, lamivudine, and tenofovir disoproxil fumarate). *New drug.
 
PREA(P):  P
 
Sponsor:  Mylan
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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