US FDA approves Teva's generic venlafaxine, the first copy version of Pfizer's Effexor XR

The US Food and Drug Administration has approved the first generic version of Pfizer's Effexor XR (venlafaxine), a drug for the treatment of major depressive disorder, for Israeli firm Teva Pharmaceutical Industries, which said it expects to start shipping the drug from tomorrow (July 1) as per the terms of it 2006 'pay-to-delay' agreement with Wyeth (now owned by Pfizer).

As the first company to file an Abbreviated New Drug Application containing a paragraph IV certification for this product, Teva says it has been awarded a 180-day period of marketing exclusivity. The brand product had annual sales of around $2.75 billion in the USA, based on IMS sales data, noted Teva.

'The approval of this widely used antidepressant is another example of the FDA's efforts to increase access to safe and effective generic drugs,' said Keith Webber, Deputy Director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research. 'Access to treatments for depression is important because depression can interfere with a person's daily life and routine, which can significantly affect relationships with family and friends,' he added.