FDA says Teva antidepressant is ineffective

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by Associated Press

kvue.com

Posted on October 4, 2012 at 8:45 AM

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.

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.

 

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