The FDA has taken the unprecedented step of making a manufacturer withdraw its generic antidepressant from the market. Budeprion XL 300 was a branded generic that was introduced in 2006 after the antidepressant Wellbutrin XL 300 lost its patent. Many consumer complaints led the FDA to investigate the bioequivalence of this product. The FDA study revealed that the generic drug did not get into the bloodstream in an identical manner to the brand name drug. As a result, they concluded that Budeprion XL 300 was not bioequivalent to Wellbutrin XL 300 and should not be marketed. Other manufacturers of long acting bupropion, the generic compound in Wellbutrin, are being asked to test their formulations for bioequivalence. They will have to submit the data on their products to the FDA no later than March, 2013.
Join Over 140,000 Subscribers at The People's Pharmacy
Each week we send two free email newsletters with breaking health news, prescription drug information, home remedies and a preview of our award-winning radio show. Join our mailing list and get the information you need to make confident choices about your health.