www.fdanews.com/articles/102118-mylan-announces-tentative-fda-approval-for-lamotrigine-tablets
Mylan Announces Tentative FDA Approval for Lamotrigine Tablets
December 12, 2007
The FDA has tentatively approved Mylan Pharmaceuticals’ abbreviated new drug application for Lamotrigine tablets 25, 100, 150 and 200 mg.
Lamotrigine tablets are the generic version of GlaxoSmithKline’s Lamictal, an antiepileptic drug.
Lamictal had U.S. sales of approximately $1.97 billion for the 12 months ending Sept. 30, according to Mylan.