Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial

摘要

Background Patients and clinicians share concerns that generic drug substitution might lead to loss of efficacy or emergence of adverse events. In this trial, we assessed US Food and Drug Administration (FDA) bioequivalence standards by studying the effects of switching between two disparate generic immediate-release lamotrigine products in patients with epilepsy.