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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:
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
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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