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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:  04/04/2016
 
Trade Name:  Descovy
 
Generic Name or Proper Name (*):  emtricitabine and tenofovir alafenamide
 
Indications Studied:  Treatment of HIV-1 infection in adults and pediatric patients 12 years of age or older
 
Label Changes Summary:  * Efficacy and safety of Descovy was established in pediatric patents aged 12 years old with body weight greater than or equal to 35 kg. * Safety and effectiveness in pediatric patients less than 12 years or less than 35 kg have not been established. * Assessment of Bone Mineral Density should be considered for adults and pediatric patients treated with Descovy who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. * Information on dosing, clinical trial and PK. * New drug.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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