Federal Agency Approves Use Of Generic Wellbutrin In Depression Patients

The U.S. Food and Drug Administration said Wednesday that a generic version of a popular name brand antidepressant is both safe and effective, despite recent consumer complaints



The federal agency reviewed the generic version of Wellbutrin manufactured by Teva after some patients reported their depression returned when they switched from the brand name drug Wellbutrin XL to the generic pharmaceutical. Some patients also complained of headaches, anxiety and other side effects.

After evaluating the reports concerning the generic version of bupropion hydrochloride extended-release 300-milligram tablets, the FDA said in its report that the generic product is "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."

In a report posted online, FDA concluded the reoccurrence of depression and other side effects are typical of patients taking antidepressants.

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.