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U.S. Department of Health and Human Services

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 adults* Information on PK parameters in neonates to < 1 year, and clinical studies
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Takeda
Pediatric Exclusivity Granted Date:  07/15/2008
Therapeutic Category:  Antiulcerative