The FDA has asked Teva Pharmaceuticals to stop shipping Budeprion XL 300, the generic alternative to the popular antidepressant Wellbutrin XL 300. Consumers have been complaining that the drug has not been effective and that they have been suffering side effects such as anxiety, headaches, and insomnia. After testing, the FDA found that the generic drug releases key ingredients faster than its branded counterpart.
To approve a generic drug, the FDA must be shown that it is chemically equivalent to the branded drug and that it produces the same medical effects as well. In the case of Budeprion, the 150-milligram version of the drug was shown in testing to be equivalent to the 150 mg version of Wellbutrin, so they assumed that the same would hold true of the 300 mg version.
The fact that this was not the case came to the attention of the FDA because of patients who complained and ConsumerLab, a small company that independently tests drugs and nutrition products.
Four other drugmakers make generic equivalents of Wellbutrin 300, and the FDA has requested that they conduct their own equivalence testing and submit the results by March 2013.
For more, visit http://www.foxnews.com/health/2012/10/04/fda-says-teva-antidepressant-is-ineffective/.