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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:  07/03/2014
 
Trade Name:  Namenda XR
 
Generic Name or Proper Name (*):  memantine hydrochloride
 
Indications Studied:  Autism spectrum disorders
 
Label Changes Summary:  The safety and effectiveness of memantine have not been established in pediatric patients Memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6-12 years with autism spectrum disorders Adverse reactions were similar to those observed in adultsInformation on dosing, adverse reactions, clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Forest Research Institute, Inc.
 
Pediatric Exclusivity Granted Date:  06/16/2014
 
NNPS:  FALSE'
 
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