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Effexor XR generic approved

The US Food and Drug Administration (FDA) has approved the first generic version of Pfizer's anti-depressant Effexor XR (venlafaxine)

The US Food and Drug Administration (FDA) has approved the first generic version of Pfizer's Effexor XR (venlafaxine) capsules, a widely used anti-depressant with annual sales of about $2.75bn in the US.

The branded drug, which was launched by Wyeth (now Pfizer) in 1993, is approved in the US for major depressive disorder and generalised anxiety disorder and is used off-label for indications including diabetic neuropathy and migraine.

The generic version of the capsules, made by Teva Pharmaceuticals, will begin shipping on July 1. That date is specified under a "pay for delay" patent settlement between Teva and Wyeth signed in 2006.

Teva will have 180 days of US marketing exclusivity for the generic product under a law that awards exclusivity to the first company to file an Abbreviated New Drug Application (ANDA) containing a patent challenge called a paragraph IV certification.

Like branded Effexor XR capsules, the generic product will carry a number of cautions, including a boxed warning indicating that anti-depressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

30th June 2010

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