FDA says Teva antidepressant is ineffective


WASHINGTON (AP) — Teva Pharmaceuticals is pulling its generic version of a popular antidepressant off the market after a federal analysis showed the pill does not work properly.

The Food and Drug Administration called on Teva to withdraw Budeprion XL 300 after chemical testing showed the drug releases its key ingredient faster than the original drug Wellbutrin, made by GlaxoSmithKline.

The action contradicts the FDA’s previous update on the issue in 2008, when regulators said the drugs are essentially the same. That review came after hundreds of patients complained that Teva’s drug did not work or caused side effects like headaches, anxiety and insomnia.


advertisement

The agency said it completed its own study of the two pills in August, which showed Budeprion does not release into the blood at the appropriate rate.

© 2012 The Associated Press. All rights reserved.

More articles filed under Business News

Leave a Comment

Please use the comment box below for general comments, but if you feel we have made a mistake, typo, or egregious error, let us know about it. Click here to "call us out." We're happy to listen to your concerns.