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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:  11/03/2017
 
Trade Name:  Vimpat
 
Generic Name or Proper Name (*):  lacosamide
 
Indications Studied:  Treatment of partial-onset seizures to patients 4 years of age and older
 
Label Changes Summary:  *Expanded the use of Vimpat tablets and oral solution for the treatment of partial-onset seizures to patients 4 years of age and older. *Use in this age group is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 to less than 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Vimpat injection in pediatric patients has not been established. *In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is based on body weight and is only recommended to be administered orally. *Adverse reactions were similar to those observed in adults. *Information on PK parameters, dosing, adverse reactions. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  UCB, Inc.
 
NNPS:  TRUE
 
Therapeutic Category:  Anticonvulsant
 
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