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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:  09/29/2008
Trade Name:  Videx EC
Generic Name or Proper Name (*):  didanosine
Indications Studied:  HIV infection in >20 kg
Label Changes Summary:  * Extended indication from adults to children weighing e20kg who can swallow capsules * Dosing is based on body weight not to exceed adult dose * Adverse events (AEs) are generally similar to those seen in adults * Information on dose, AEs, population PK analysis, lab abnormalities, and historical clinical studies
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:  08/13/2001
Therapeutic Category:  Antiviral