Generic Version of Wellbutrin Pulled from the Market

Dr. Sharon Orrange
Dr. Orrange is an Associate Professor of Clinical Medicine in the Division of Geriatric, Hospitalist and General Internal Medicine at the Keck School of Medicine of USC.
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So does my bupropion XL even work? That is the question my patients have been asking the last two weeks. I wonder too. Here is what we know thus far:

• On October 3, 2012, the FDA announced that Budeprion XL 300 mg (bupropion extended-release tablets), marketed by Teva Pharmaceuticals, is not therapeutically equivalent to Wellbutrin XL 300 mg and it was withdrawn from the market. So, it didn’t work the way Wellbutrin XL worked. That’s disconcerting.

• The same company makes Budeprion XL 150 mg and plans on continuing to make that dose.

• While there are 5 other generic versions of Wellbutrin XL 300 mg (bupropion XL 300 mg) here is the catch: each of these generics was approved on the basis of bioequivalence studies comparing the 150-mg strength of the products to Wellbutrin XL 150 mg.

• Studies were not performed directly on the 300-mg strength of the products. So make sure you understand this: the bioequivalence studies were performed using the 150-mg strength, and the results were extrapolated to establish bioequivalence of the 300-mg product.

• The FDA has now asked the other makers of Bupropion 300 mg XL to conduct their own studies to assess the bioequivalence of their 300 mg bupropion extended-release tablets to Wellbutrin XL 300 mg.

Physicians and patients are now leery of whether Bupropion XL 300 mg is as effective as the brand name Wellbutrin. The brand name Wellbutrin costs our patients more than $300 a month and that’s a tall order to ask of patients. At this point those of you using bupropion XL 300 mg with good results should probably talk to your physician about staying on it, and those of you not finding it effective should think about a change.

Thoughts?

Dr. O.

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