The first generic formulation of the antidepressant venlafaxine has been approved by the Food and Drug Administration.
The FDA announced in early August that it had approved the generic version of the immediate-release formulation of Effexor in 25-mg, 37.5-mg, 50-mg, 75-mg, and 100-mg tablets, the same doses available for Effexor. The generic manufacturer, Teva Pharmaceuticals USA, announced that shipment of the tablets would start immediately.
Teva has exclusive rights to market the generic formulation for 180 days after approval, after which time the FDA can approve applications for other generic formulations of venlafaxine, a serotonin norepinephrine reuptake inhibitor (SNRI).
Effexor, marketed by Wyeth Pharmaceuticals Inc., was approved for major depressive disorder in 1993; the extended-release formulation (Effexor XR) was approved in 1997.
Other recently approved first-time generic drugs include escitalopram tablets, the generic version of the selective serotonin reuptake inhibitor (SSRI) Lexapro, and sertraline in tablet and oral concentrate formulations, the generic version of the SSRI Zoloft.