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FDA Pulls One Generic Form of Wellbutrin Off the Market
Date:12/5/2012

By Carina Storrs
HealthDay Reporter

WEDNESDAY, Dec. 5 (HealthDay News) -- People taking the antidepressant Wellbutrin now have one less option for a generic version of the drug.

In October, the U.S. Food and Drug Administration recommended that generic Wellbutrin, or bupropion, made by Impax Laboratories and distributed by Teva Pharmaceuticals, be taken off the market, and Impax and Teva have agreed to stop shipping the drug.

The decision is based on an FDA study that found that the extended release (XL) form of bupropion -- Budeprion XL -- at the 300 milligram (mg) dose was not bioequivalent to brand-name Wellbutrin XL at the same dose, suggesting that it may not be as safe and effective.

The study was published Dec. 5 in the New England Journal of Medicine.

Four other manufacturers make bupropion XL in 300 mg tablets, and patients can still get their prescription filled with these products.

"The other four generic versions of 300 mg extended-release bupropion tablets are not affected by FDA's recent announcement," said FDA spokesperson Sandy Walsh.

Although the agency stated that lack of bioequivalence might only apply to the Impax/Teva product because of its unique formulation, the agency is requesting that the other four manufacturers submit bioequivalence data to the agency by March 2013.

"This kind of result puts a cloud over all of the generic XL [forms of bupropion]," said Dr. David Hellerstein, a professor of psychiatry at Columbia University Medical Center, in New York City.

Companies including Impax/Teva also make a bupropion XL in 150-mg tablets, which are also not affected by the FDA decision.

But even before the FDA decision, Hellerstein avoided any kind of generic bupropion XL. "Patient would complain that generic XL is not the same as brand-name XL -- it wears off sooner, it has more side effects," he said. "I tell patients not to go to XL unless you're
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