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BioPharmaceutical North America United States

Generic Bupropion XL Reevaluation Running Behind Schedule

This article was originally published in The Pink Sheet Daily

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Executive Summary

FDA has received data from just one of four bioequivalence studies of 300 mg bupropion extended-release generics it requested by March from sponsors following Impax/Teva’s withdrawal of their generic version due to lack of bioequivalence.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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