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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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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
BPCA(B):
B
Sponsor:
Novalar Pharmaceuticals, Inc.
Pediatric Exclusivity Granted Date:
08/19/2015
NNPS:
FALSE
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