FDA boots Wellbutrin generic
Generic Wellbutrin got yet another knock for lack of bioequivalence. This time, however, the FDA found that a 300mg tablet made by Actavis was the problem.
Regulatory Focus reports that the FDA posted a note on its website dated Oct. 10 that found the generic antidepressant was not the bioequivalent of GlaxoSmithKline's Wellbutrin. The FDA said the Actavis formulation “had different formulation design as the reference product so that the generic product releases earlier in the gastrointestinal (GI) tract.”
The FDA found a Wellbutrin generic made by Impax and distributed by Teva failed the bioequivalence test in 2012. This finding was based on reports that started to flow into the regulator in 2007.