Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Depression Health Center

Font Size

High-Dose Generic Wellbutrin XL Withdrawn

WebMD Health News
Reviewed by Louise Chang, MD

Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.

The FDA action comes five years after patients complained of headaches and returning depression after switching from brand-name Wellbutrin XL to Teva's generic version. The Teva generic was approved in December 2006.

In 2009, the FDA wrongly assured patients that the Teva generic worked just as well as the name brand. But it wasn't until 2010 that the FDA finally decided to test the full-dose version of the drug. Those tests, completed just weeks ago, found that instead of proper extended release, Teva's drug dumped too much active ingredient too soon and failed to maintain effective drug levels.

The FDA tests in people finally came to the same conclusion as October 2007 lab tests by Tod Cooperman, MD. Cooperman's for-profit company, the ConsumerLab web site, tests nutritional supplements and generic drugs for potency and accurate labeling.

"The generic did not act like a once-a-day formula but more like an immediate-release formula," Cooperman says.

Teva and Impax Laboratories, which makes the drug for Teva, have recalled the drug. The lower-dose version, Budeprion XL 150 mg, remains on the market. FDA's waived tests of the now-withdrawn 300-mg version of the drug based on tests of the lower-dose version -- a process called "waiving up."

The FDA defended the practice, noting that generic drugs are tested on small numbers of healthy volunteers to see if they work the same as (are "bioequivalent" to) brand-name drugs. The agency was reluctant to expose these volunteers to the side effects of the higher-dose drug.

"A less cautious approach in studying the bioequivalencies of Budeprion XL 300 mg could have brought the data to light earlier," the FDA admits on its web site.

Alternative Generic Wellbutrin Products

Four other companies make generic, extended-release versions of Wellbutrin XL 300 mg: Anchen, Watson, Actavis, and Mylan.

However, the FDA has asked each of these manufacturers to test the drugs at full dose to see if they truly are the same as the brand-name antidepressant.

It's likely they are. Most of the complaints received by the FDA concerned the Teva/Impax drug.

Today on WebMD

Differences between feeling depressed and feeling blue.
jk rowling
Famous people who've struggled with persistent sadness.
depressed man sitting on hallway floor
Learn the truth about this serious illness.
Sad woman looking out of the window
Tips to stay the treatment course.
unhappy teen boy
Health Check
jk rowling
Pills with smiley faces
Teen girl huddled outside house
Depressed man sitting in hospital hallway
antidepressants slideshow
pill bottle
Winding path