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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Sucampo Pharma Americas, LLC
 
NNPS:  FALSE
 
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