Teva Pharmaceutical Industries Ltd. (TEVA) and Impax Laboratories Inc (IPXL), are facing a class action lawsuit over allegations that Budeprion XL, their generic formulation of anti-depressant Wellbutrin XL, is less effective than Wellbutrin XL.
According to a report in today's Wall Street Journal, the suit, filed in California, states "It is scientifically proven that Budeprion XL contains an inferior delivery mechanism to that contained in Wellbutrin XL. That inferior delivery system results in a much more rapid, and potentially harmful, release of Budeprion XL's key ingredient to end-use consumers. The result is that Budeprion XL is less effective in treating depression and, indeed, is much more likely to cause certain dangerous side effects, as compared to Wellbutrin XL."
The allegations remain to be proved, and the US Food and Drug Administration (FDA) currently considers the drug to be safe, based on its evaluation of reports of side effects from users of generic Wellbutrin. However, the FDA may request a special clinical trial to further evaluate the generic formulation, although that has yet to be confirmed.
The plaintiffs in the lawsuit are seeking reimbursement of prescription costs paid for the generic drug, plus interest, and other, non-specified costs.
JUN-05-09: Teva, Impax Face Class-Action Suit For Generic Wellbutrin [WJS: TEVA, IMPAX SUED OVER GENERIC ANTIDEPRESSANT]
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Posted on Jun-5-09
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