Full article reprinted from "The Pink Sheet" -September 30, 2008
Read about why the FDA considers how best to address continued concerns about generics for Wellbutrin XL (bupropion extended-release tablets), one issue it may wrestle with is whether it should conduct bioequivalence studies at the highest dose, 300 mg, which has a higher risk of seizures.
Full article reprinted from "The Pink Sheet" -September 30, 2008
FDA Revisits Wellbutrin Generics – Again; Will Teva Fund A High-Dose Study?
As FDA considers how best to address continued concerns about generics for Wellbutrin XL (bupropion extended-release tablets), one issue it may wrestle with is whether it should conduct bioequivalence studies at the highest dose, 300 mg, which has a higher risk of seizures.
The agency said it has "agreed to look into doing a study that would test the drug in patients that have reported problems with the product," but "there is no information available yet on what type of study may be done."
Industry sources say the study hinges on funding from the manufacturer. Teva, who distributes the generic for manufacturer Impax, may be willing to participate in a study, the sources said. Teva officials had no comment.
The potential collaborative study stems from a meeting this summer with the agency, requested by People's Pharmacy co-founder Joe Graedon, to address the hundreds of reports Graedon's Web site had received from patients experiencing adverse events and loss of effectiveness when switching from GlaxoSmithKline's antidepressant Wellbutrin XL to Budeprion XL, the brand name of the generic.
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