Federal Register Notice: FDA has determined that GlaxoSmithKline’s antiepileptic drug Lamictal (lamotrigine) tablets, 50 mg and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for lamotrigine tablets, 50 mg and 250 mg, if all other legal and regulatory requirements are met. FDA approved Glaxo’s NDA for Lamictal including 50 mg and 250 mg strengths on 12/27/94, but the company never marketed the 50 mg and 250 mg strengths. To view this notice, click here.