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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
 
NNPS:  TRUE'
 
Therapeutic Category:  Antiviral
 
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