The US Food and Drug Administration (FDA) has approved the first generic copy of Forest Laboratories’ Lexapro to treat depression and generalised anxiety disorder in adults.
The generic drug (escitalopram) was approved yesterday – on the same day Forest Laboratories’ patent expired – and was introduced to the market by Teva Pharmaceutical Industries and IVAX Pharmaceuticals.
Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA cannot approve another generic version of escitalopram tablets before the end of that period.
FDA’s Center for Drug Evaluation and Research director Janet Woodcock commented on the approval, "This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options."
In the clinical trials for Lexapro, the most commonly observed adverse reactions were sleeplessness, ejaculation disorder, nausea, and an increase in sweating and fatigue.
Escitalopram and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
