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:  07/12/2016
 
Trade Name:  Effient
 
Generic Name or Proper Name (*):  prasugrel
 
Indications Studied:  Vaso-occlusive crises in pediatric patients with sickle cell disease
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients have not been established. *In a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met.
 
BPCA(B) and PREA(P):  B
 
Sponsor:  Lilly
 
Pediatric Exclusivity Granted Date:  05/23/2016
 
NNPS:  FALSE
 
-
-