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FDA Withdraws Generic Budeprion



12/6/2012 11:17:45 AM

The Food and Drug Administration (FDA) has pulled bupropion, the generic form of the antidepressant drug Wellbutrin, off the market. The decision was made after analysis showed the generic form of the bupropion, 300 mg dose, was not bioequivalent to its Wellbutrin counterpart. The discovery led to Impax Laboratories and distributor Teva Pharmaceuticals having to stop distribution of the medication due to efficacy and safety concerns. “The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to Wellbutrin XL 300 mg,” said the FDA in a statement. “This announcement relates only to Budeprion XL 300 mg manufactured by Impax and marketed by Teva. It does not affect the Impax/Teva Budeprion 150 mg product or generic bupropion products made by other manufacturers.” Bupropion has historically been used as an inexpensive alternative to Wellbutrin, given to patients who have a need for antidepressant medication. It is currently approved for the treatment of severe depression, and according to the National Alliance on Mental Illness, the medication can also be used for seasonal affective disorder and to aid in smoking cessation. In serious cases, the drug has been used to help women stop smoking during pregnancy.

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