The FDA has withdrawn approval of Impax (IPXL -1%) and Teva's (TEVA -0.5%) Budeprion XL 300 mg,...

|By:, SA News Editor

The FDA has withdrawn approval of Impax (IPXL -1%) and Teva's (TEVA -0.5%) Budeprion XL 300 mg, saying it's reviewed new data that indicates it's not therapeutically equivalent to Wellbutrin XL 300 mg. Both companies have stopped shipping the product and are issuing detailed information to their customers. The FDA added that its announcement does not affect the Impax/Teva Budeprion 150 mg product or generic Budeprion products made by other manufacturers.