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BioPharmaceutical North America United States

Generics May Have Tmax Flexibility, FDA Says

This article was originally published in The Pink Sheet Daily

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Executive Summary

Several hours of Tmax difference between brand Wellbutrin XL and generic bupropion is not critical to the drug’s efficacy given that it can take weeks to reach the drug’s desired effect, FDA determined.

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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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