FDA Takes Generic Antidepressant Budeprion XL 300 mg Off the Market
Following a review of new data, the FDA has concluded that the antidepressant medication Budeprion XL 300 mg is not therapeutically equivalent to GlaxoSmithKline's Wellbutrin 300 mg.
Budeprion XL 300 mg is one of the generic versions of Wellbutrin XL 300 mg that was approved by the FDA in 2006. It is manufactured by Impax Laboratories Inc. (IPXL) and is marketed by Teva Pharmaceuticals USA Inc.
In a bioequivalence study that compares Budeprion XL 300 mg to Wellbutrin XL 300 mg, it was found that the Budeprion XL 300 mg tablets fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg.
Other manufacturers of generic versions of Wellbutrin XL 300 mg include Anchen Pharmaceuticals Inc., Actavis, Watson Pharmaceuticals Inc. (WPI), and Mylan Inc. (MYL). Each has been asked to conduct their own studies to assess the bioequivalence of their 300 mg extended-release bupropion tablets to Wellbutrin XL 300 mg. They have until March 2013 to submit the data from those studies to the FDA.
Last week the FDA stated that Impax and Teva have stopped shipping Budeprion XL 300 mg, but noted that their 150 mg product and generic bupropion products made by other manufacturers are not affected.