The United States Food and Drug Administration (FDA) has specific rules which generic drug
companies must follow to get a generic copy of a seizure medication approved. Currently, FDA
approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and
who take just one dose of the generic drug followed by a series of blood tests. Some people
with epilepsy and their physicians have complained about side effects or loss of seizure
control when taking generic drugs, but no one knows if these complaints are truly because of
problems with the generic drugs.
This research is to determine whether several different generic versions and the brand
version of the medication lamotrigine perform in a similar way when given to people with
The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be
tested are approved by the FDA for the treatment of seizures.