Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee

Committee Meeting on March 10, 2011, from 8 a.m. to 5 p.m.

Agenda: On March 10, 2011, the committee will discuss, in general, the use of historical-controlled trials for the approval of anticonvulsant monotherapy for seizures of partial origin for antiepileptic drug products that are already approved for adjunctive therapy. The committee will also discuss how this may specifically apply to the approval of the supplemental new drug application 022115/S–011, LAMICTAL XR (lamotrigine extended release tablets), sponsored by SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug.