Lamictal® (GlaxoSmithKline) FDA approved
for:
8.24.98 adjunctive treatment of partial seizures in adults;
adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult
patients
12.14.98 conversion to monotherapy in adults with partial seizures who are
receiving treatment with a single enzyme-inducing anti-epileptic drug (EIAED)
6.20.2003 the
maintenance treatment of Bipolar I
Disorder to delay the time to occurrence of mood episodes (depression,
mania,
hypomania,
mixed episodes) in patients treated
for acute mood episodes with standard therapy
9.22.2006 treatment of primary generalized tonic clonic seizures in adults and
pediatric patients (2 years of age or older)
WARNING I
WARNING II U.S. Prescribing information
Lamictal®
XR™ (GlaxoSmithKline) FDA approved
for: 1.29.2010 adjunctive therapy for primary generalized tonic-clonic (PGTC)
seizures and partial onset seizures with or without secondary generalization
in patients ≥13 years of age. U.S. Prescribing information