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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:
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
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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