FDA Reaffirms Bioequivalence Of Wellbutrin Generic

Law360, New York (April 18, 2008, 12:00 AM EDT) -- Despite reports of 85 patients experiencing “undesirable effects” after switching from GlaxoSmithKline’s antidepressant Wellbutrin XL to a generic version marketed by Teva Pharmaceuticals Industries Ltd., the U.S. Food and Drug Administration has insisted that the drugs are equivalent.

On Wednesday, the FDA revealed the results of its review of the equivalence between Wellbutrin XL and Teva’s generic bupropion XL product after reported cases in which patients reported a loss of antidepressant effect after switching from Wellbutrin to the generic drug.

“Given the temporal relationship between the...
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