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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:  06/17/2004
Trade Name:  Prevacid
Generic Name or Proper Name (*):  lansoprazole
Indications Studied:  Short-term treatment of symptomatic GERD and erosive Esophagitis
Label Changes Summary:  * Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age * Safety and effectiveness in pediatric patients <1 year of age have not been established * Information on dose, PK parameters, and AE profile
Product Labeling:  Labeling  Opens a new window
Sponsor:  Tap
Pediatric Exclusivity Granted Date:  07/15/2008
Therapeutic Category:  Antiulcerative