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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:  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  Opens a new window
 
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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