Teva/Impax generic Wellbutrin XL 300mg pulled from US market on non-bioequivalence grounds

Following a review of new data, the US Food and Drug Administration says these indicate that Budeprion XL 300mg (bupropion hydrochloride extended-release tablets), a generic version of UK pharma giant GlaxoSmithKline’s (LSE: GSK) Wellbutrin, is not therapeutically equivalent to the originator antidepressant drug. The agency found that the copy 300mg version failed to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300mg.

Manufacturer Impax Laboratories (Nasdaq: IPXL) has requested that the FDA withdraws approval of budeprion XL 300mg extended-release tablets. Impax and marketing partner Israel-headquartered generics giant Teva Pharmaceutical (NYSE: TEVA) have stopped shipping the product and are issuing detailed information to their customers. This announcement relates only to Budeprion XL 300mg manufactured by Impax and marketed by Teva. It does not affect the Impax/Teva Budeprion 150mg product or generic bupropion products made by other manufacturers.

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