FDA Withdraws Approval of a Generic Version of Wellbutrin

The U.S. Food and Drug Administration said Wednesday the product, Budeprion XL 300 milligrams, which is manufactured by Impax Laboratories Inc. and marketed by Teva Pharmaceuticals USA Inc., “is not therapeutically equivalent to Wellbutrin XL 300 mg” or the extended-release version of Wellbutrin. Impax has requested that the FDA withdraw approval of the product, the agency said. Impax and Teva have stopped shipping the product.

Learn more about the decision to withdraw approval of Budeprion XL 300mg…

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