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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 adultsInformation 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
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiulcerative
 
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