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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:  03/20/2008
 
Trade Name:  Prilosec
 
Generic Name or Proper Name (*):  omeprazole
 
Indications Studied:  Maintenance healing of erosive esophagitis
 
Label Changes Summary:  * Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial * Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. * Safety and effectiveness in children less than 1 year of age have not been established * Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  05/01/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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