Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
-
-