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Teva, Impax To Pull Generic Wellbutrin After FDA Finding

Law360, New York (October 4, 2012, 9:23 PM EDT) -- The U.S. Food and Drug Administration said Wednesday that Teva Pharmaceuticals USA Inc. and Impax Laboratories Inc. would remove a generic version of the antidepressant Wellbutrin XL from the market following the agency's determination it is not equivalent to the brand-name version.

New data shows that the 300-milligram dose of Budeprion XL, manufactured by Impax and marketed by Teva, is not therapeutically equivalent to the same dose of GlaxoSmithKline's Wellbutrin XL, according to the FDA.

Impax and Teva have stopped shipping the drug, and Impax asked...
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