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Oct 08, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Budeprion XL bupropion regulatory update

Impax and Teva pulled a generic version of antidepressant Wellbutrin XL bupropion 300 mg from the market after FDA determined the generic is not bioequivalent to the branded product. FDA approved the generic in 2006 based on an extrapolation of bioequivalence data from a 150 mg dose. However, in 2007 the agency received reports of...

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