Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-