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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:
04/30/2018
Trade Name:
Amitiza
Generic Name or Proper Name (*):
lubiprostone
Indications Studied:
Pediatric Functional Constipation (PFC)
Label Changes Summary:
*Safety and effectiveness have not been established in pediatric patients less than 6 years. *Effectiveness has not been established in pediatric patients 6 years and older. Efficacy was not demonstrated for the treatment of PFC in a 12 week, randomized, double-blind, placebo controlled trial conducted in 606 patients 6 to 17 years with PFC comparing Amitiza to placebo. *Adverse reactions were similar to those reported in adults. *Information on clinical trial. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Sucampo Pharma Americas, LLC
NNPS:
FALSE
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