• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
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
Therapeutic Category:  Antiviral