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Version of Generic Wellbutrin Withdrawn from the Market — Physician’s First Watch

Medical News |
October 5, 2012

Version of Generic Wellbutrin Withdrawn from the Market

A generic version of bupropion, distributed by Teva Pharmaceuticals as Budeprion XL 300 mg, has been pulled from the market after an FDA analysis found that it was not therapeutically equivalent to brand-name Wellbutrin XL 300 mg.

Soon after Budeprion's approval in December 2006, some patients who switched from 300-mg Wellbutrin to Budeprion reported reduced efficacy. A subsequent FDA-sponsored bioequivalence study found that the 300-mg Budeprion tablets released less of the active ingredient into the bloodstream and at a slower rate than Wellbutrin.

The decision to pull the drug does not affect the 150-mg dose of Budeprion or the four other generic bupropion products. However, the FDA did ask other generic manufacturers to conduct their own bioequivalence studies on 300-mg formulations.

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