Zdrowie i gospodarka · 05/03/2007

FDA Clears Path for LAMICTAL Tablets to be Approved via Abbreviated New Drug Applications

The Food and Drug Administration (FDA) has determined that LAMICTAL (lamotrigine) tablets, 50 milligrams (mg) and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. This decision will enable the FDA to approve abbreviated new drug applications (ANDAs) for lamotrigine tablets, 50 mg and 250 mg, provided all other regulatory requirements are fulfilled.