The Food and Drug Administration reported this week that the 300 mg dose of generic bupropion, sold under the name Budeprion XL and made by Impax Laboratories and Teva Pharmaceuticals is being removed from the market because it doesn’t work as it should. The move does not apply to the brand name version of the drug, Wellbutrin XL, or other generic versions of bupropion. But the FDA has asked four other drug makers to test the 300 mg strength of their generic versions of bupropion to make sure they work properly.
The FDA’s action is based on a study it conducted in 24 adults that found generic Budeprion XL 300 mg is not released into the bloodstream at the same rate and in the same amount as branded Wellbutrin XL 300 mg. This means Budeprion XL might not deliver the same antidepressant benefits as Wellbutrin XL. And it could explain reports from people who said their depression symptoms worsened after they switched from Wellbutrin XL to Budeprion XL.
The FDA said it believes the problem is limited to Budeprion XL 300 mg, but it has requested that four other manufacturers, Actavis, Anchen, Mylan, and Watson, which make their own 300 mg generic bupropion tablets, conduct studies to show their pills are equivalent to Wellbutrin XL 300 mg. FDA has asked that those results be submitted by March 2013. Previous research to gain the generic approval from the FDA showed the Budeprion XL 150 mg pill is equivalent to Wellbutrin XL 150 mg.
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