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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:  05/23/2019
 
Trade Name:  Lyrica
 
Generic Name or Proper Name (*):  pregabalin
 
Indications Studied:  Treatment of partial-onset seizures (POS), to include pediatric patients 1 month to less than 4 years
 
Label Changes Summary:  *Safety and effectiveness as adjunctive treatment for POS in pediatric patients 1 month to less than 4 years have been established in a 14-day double-blind, placebo-controlled study (N=175). Previously approved in 4 years and older. *The youngest subject evaluated was 3 months of age; use in patients 1 month to less than 3 months of age is supported by additional pharmacokinetic analyses. *Safety and effectiveness in pediatric patients below the age of 1 month have not been established. *The most common dose-related adverse reactions (>5%) with Lyrica in this study were somnolence, pneumonia, and viral infection. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  PF Prism CV
 
Pediatric Exclusivity Granted Date:  11/21/2018
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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