FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg
October 3, 2012
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. FDA has changed the therapeutic equivalence rating for this product in the Agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book1) 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.
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