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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:
10/28/2008
Trade Name:
Prevacid
Generic Name or Proper Name (*):
lansoprazole
Indications Studied:
Symptomatic GERD in infants
Label Changes Summary:
Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Takeda
Pediatric Exclusivity Granted Date:
07/15/2008
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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