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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:
05/02/2013
Trade Name:
Sustiva
Generic Name or Proper Name (*):
efavirenz
Indications Studied:
Treatment of HIV-1 infection
Label Changes Summary:
Labeling updated with dosing recommendations for pediatric patients 3 months - 3 years and weighing at least 3.5 kg Use in pediatric patients < 3 months OR less than 3.5 kg body weight is not recommended because the safety, pharmacokinetics, and antiviral activity have not been evaluated and there is a risk of developing HIV resistance if efavirenz is underdosed. Information on population PK, safety, virologic, and immunologic response from 3 open-label clinical trials in patients 3 months - 21 years.Postmarketing study
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B,P
Sponsor:
Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:
01/29/2013
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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