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:  02/28/2018
 
Trade Name:  Cimduo
 
Generic Name or Proper Name (*):  lamivudine and tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of HIV-1 infection in adult and pediatric patients weighing at least 35 kg
 
Label Changes Summary:  *Safety and effectiveness as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue CIMDUO as clinically appropriate. *New drug.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Mylan
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
-
-