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Will Withdrawal Of Generic Bupropion XL Resurrect Product Liability Litigation?

Executive Summary

Personal injury firms began looking for clients after FDA announced that Impax/Teva’s generic product was not equivalent to GSK’s Wellbutrin XL, but Supreme Court’s Mensing decision may keep cases from getting off the ground.

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Generic Bupropion XL Must Be Retested; Teva/Impax 300 mg Withdrawn After Efficacy Concerns

In what appears to the first downgrade of a generic equivalency based on patient complaints, FDA changes the high dose of the Teva/Impax product from AB to BX. The four other generic manufacturers of 300 mg bupropion extended-release must conduct their own bioequivalence tests, but FDA does not expect problems because they are differently formulated than the Teva/Impax version.

Generics Liability Bill Could Face Uphill Road In Senate

Sen. Leahy plans to introduce legislation to overturn the Supreme Court’s ruling in Pliva v. Mensing; the attorney who represented generic manufacturers in that case says the legislation is unlikely to pass.

Post-Mensing Blues: Generic Mfrs. Still Face Product Liability Claims

While the Supreme Court’s ruling last year found that failure-to-warn claims against generic manufacturers are preempted by federal law, some courts have refused to dismiss all claims.

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