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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:  01/18/2012
 
Trade Name:  Viread
 
Generic Name or Proper Name (*):  tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of HIV infection in combination with other antiretroviral agents
 
Label Changes Summary:  *Viread tablets: Expanded the indication from adults to pediatric patients 2 - < 12 years, weighing greater than or equal to 17 kg, who can swallow an intact tablet; tablet previously approved for use in 12 years and older * Viread Oral Powder: Expanded the indication from adults to pediatric patients 2 years of age and older * Safety and effectiveness in patients <2 years have not been established *Viread oral powder should be mixed in a container of soft food not requiring chewing (e.g., applesauce, baby food, yogurt) and ingested immediately to avoid a bitter taste *Adverse reactions were similar to those observed in adults *Postmarketing study, new dosage form
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Gilead
 
Pediatric Exclusivity Granted Date:  09/06/2011
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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