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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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.
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