The U.S. Food and Drug Administration said new data indicate that the generic version of the popular antidepressant Wellbutrin is not equivalent to the original drug manufactured by GlaxoSmithKline.
Budeprion XL 300 mg, or bupropion hydrochloride extended-release tablets, are manufactured by Impax Laboratories Inc and marketed by Teva Pharmaceuticals USA Inc.
The FDA, in a notice posted on its website on Wednesday, said it has changed the therapeutic equivalence rating for the product in the agency's Approved Drug Products with Therapeutic Equivalence Evaluations to show that Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg. Concerns over its effectiveness date back to 2007 when patients started complaining of multiple side effects, including headaches, anxiety and insomnia.
Impax has requested that the FDA withdraw approval of budeprion XL 300 mg extended-release tablets, the FDA said. Impax and Teva have stopped shipping the product, the agency said.