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:  08/24/2015
 
Trade Name:  Promacta
 
Generic Name or Proper Name (*):  eltrombopag
 
Indications Studied:  Treatment of thrombocytopenia in adult and pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
 
Label Changes Summary:  *Safety and efficacy in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled trials. *Safety and efficacy in pediatric patients younger than 1 year with ITP have not yet been established. *Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established. *Patients with East Asian ancestry have higher eltrombopag exposure. Dosing adjustments are needed in pediatric patients 6 years and older with East Asian ancestry and in hepatic impairment. *Information on dosing, preparation of oral suspension, PK parameters, clinical trials, adverse events.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novalar Pharmaceuticals, Inc.
 
Pediatric Exclusivity Granted Date:  08/19/2015
 
NNPS:  FALSE
 
-
-