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
Pediatric Studies Characteristics - Detail
FDA Home
Pediatrics
Pediatric Studies Characteristics
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.
Approval Date:
05/08/2009
Trade Name:
Lamictal
Generic or Proper Name (*):
lamotrigine
Indications Studied:
Adjunctive treatment for partial seizures in pediatric patients 1 24 months
Therapeutic Category:
Anticonvulsant
Ages Studied:
1-24 months
Study #:
2
Study Type:
Safety
Study Design:
Other
No Patients:
206
No Centers:
14
No Countries:
14
BPCA(B), PREA(P):
B
Asian:
2
Black:
9
Other:
8
White:
171
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
14
Non-Hispanic/Non Latino:
0
-
-