The Food and Drug Administration has asked Teva Pharmaceuticals to stop shipping Budeprion XL 300, its generic version of Wellbutrin after new testing has found the generic drug to be ineffective. Wellbutrin is prescribed to treat anxiety, depression and symptoms of nicotine withdrawal. To be approved by the FDA generic drugs are required to be chemically identical to the original drugs.
The FDA’s move to pull Budeprion XL 300 runs counter to it’s previous notice when it said in 2008 that Wellbutrin and Budeprion XL 300 were fundamentally the same. That announcement came after hundreds of patients complained that Budeprion XL 300 did not work as well as Wellbutrin, or had caused side effects including anxiety, headaches and insomnia. Yesterday, the FDA explained why there was a change. “Based on the information we had available at that time we concluded that the 150 milligram strength was doing what it should, and that it was acceptable to extrapolate those findings to the 300 milligram strength,” said Barbara Davit, director of bioequivalence for the FDA’s office of generic drugs. However, because of continuing criticism the drug agency officials decided to test it again. Dr. Gregory Geba, the FDA’s director for generic drugs added, “the role of patients and health care professionals in sharing their experiences with generic versions of Wellbutrin XL 300 mg contributed to further studies, which led to this action.”
There are several other generic drug makers who market 300 mg versions of Wellbutrin. They include Anchen, Actavis, Watson and Mylan. These drug makers have been asked to do their own studies on the equivalence of their drugs and to submit their results to the FDA by March 2013. The FDA added that patients taking the 300 mg dose of Budeprion XL account for 2% of the U.S. market for the drug, and patients with a prescription for it should call their doctor…… Huffpost Healthy Living 1/4/12