FDA Says Budeprion Antidepressant is Safe

The U.S. Food and Drug Administration announced it has determined the generic antidepressant Budeprion XL is both safe and effective.

The agency said it had received reports of loss of antidepressant effect, and new or worsening side effects, in some patients who switched from the brand name drug Wellbutrin XL to the generic pharmaceutical.

The FDA said it evaluated the reports concerning the generic version of bupropion hydrochloride extended-release 300-milligram tablets and found the generic product to be a safe and effective choice for consumers in treating depression, as it has been shown to meet all requirements for approval, including bioequivalence to the branded drug, Wellbutrin XL 300-milligram.

Wellbutrin XL is owned by GlaxoSmithKline of Philadelphia, and manufactured by Biovail of Mississauga, Ontario.

Budeprion XL is manufactured by Impax Laboratories of Hayward, Calif., and distributed by Teva Pharmaceuticals of North Wales, Pa.

The complete FDA review is available at www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm