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FDA says one type of generic 300 mg Wellbutrin XL antidepressant is ineffective

Consumer Reports News: October 05, 2012 03:44 PM

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.

Bottom line: If you take generic bupropion 300 mg, check your prescription pill bottle. If it contains the brand name "Budeprion XL" or it lists either Impax or Teva as the manufacturer, contact your doctor or pharmacist for an alternative. Budeprion XL 300 mg is an oval-shaped, yellow tablet with "682" showing on one side (a picture of the pill is shown here). If you are unsure about whether your medication is Budeprion XL 300 mg, or which company manufactured it, call your pharmacy to ask, they should be able to tell you. Do not stop taking the drug on your own.

If you take 300 mg of generic bupropion from another manufacturer, and you have concerns about its effectiveness, you might want to consider talking with your doctor about switching to another antidepressant anyway, since it is still unclear if the other four manufacturers' 300 mg tablets are equivalent to Wellbutrin XL. Budeprion XL 150 mg is not affected by the FDA's announcement.

In addition to generic bupropion, our CR Best Buy Drugs report on antidepressants recommends generic citalopram, generic fluoxetine, generic paroxetine, and generic sertraline as initial antidepressant treatment options to consider. Those medicines are substantially less expensive than the brand-name antidepressants and are as effective and safe as any of them for initial treatment of depression. But individual antidepressants can cause different side effects, so if there are certain issues you wish to avoid, discuss that with your doctor.


FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg [FDA announcement]

Steve Mitchell

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