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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:
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
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