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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
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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