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FDA Withdraws Approval of Generic Antidepressant

Agency finds that Budeprion XL is not equivalent to Wellbutrin XL (Oct. 3)

The FDA announced on October 3 that it has reviewed new data indicating that 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.

The FDA has changed the therapeutic equivalence rating for this product in the agency’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) from AB to BX, signifying that Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg.

Impax has requested that the agency withdraw approval of Budeprion XL 300-mg extended-release tablets. Impax and Teva have stopped shipping the product and are issuing detailed information to their customers.

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. Budeprion XL 300 mg was approved in December 2006. Soon after, the FDA began to receive reports that patients who were switched from Wellbutrin XL 300 mg to its generic counterparts were experiencing reduced efficacy. The FDA analyzed those reports and concluded that the complaints appeared to be linked to the Impax/Teva product.

In 2010, the FDA decided to sponsor a bioequivalence study comparing Budeprion XL 300 mg with Wellbutrin XL 300 mg. This study was conducted in 24 healthy adult volunteers and was designed to measure both the rate and the extent of release of bupropion into the blood. The results of this study became available in August 2012 and showed that Budeprion XL 300-mg tablets fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg.

The FDA has not identified any new safety information associated with Budeprion XL 300 mg; however, in some patients, the drug may not provide the desired efficacy.

For more information, visit the FDA Web site.

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