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Generic Bupropion XL Must Be Retested; Teva/Impax 300 mg Withdrawn After Efficacy Concerns

This article was originally published in The Pink Sheet Daily

Executive Summary

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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