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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:
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
BPCA(B):
B
Sponsor:
Forest Research Institute, Inc.
Pediatric Exclusivity Granted Date:
06/16/2014
NNPS:
FALSE'
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