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FDA Recalls Approval for Budeprion XL, Generic Wellbutrin XL


October 5, 2012 — The U.S. Food and Drug Administration (FDA) has withdrawn approval for high-dose generic Wellbutrin XL (sold as Budeprion XL 300) because the generic drug is not equivalent to the brand-name drug. This is an about-face for the FDA, which has insisted since 2008 that the two drugs are the same, despite hundreds of consumer complaints and independent studies showing that Budeprion XL releases its active ingredients much faster than Wellbutrin XL.

In an unusual situation, the patent on Wellbutrin XL expired, but the patent on its special time-release mechanism did not. When the generic drug company Teva Pharmaceuticals sold generic Wellbutrin XL under the brand-name Budeprion XL, the generic drug lacked the patented time-release mechanism.

The difference caused hundreds of people to submit complaints to the FDA, after they suffered from headaches, anxiety, insomnia, recurrent depression, and other serious side effects when they switched from brand-name to generic Wellbutrin XL.

Consumer advocacy organizations have been calling on the FDA to address the situation since 2007. ConsumerLabs, a for-profit advocacy organization that tests drugs and supplements, paid an independent lab to compare Wellbutrin XL and Budeprion XL. They found that Budeprion released its active ingredients much faster than Wellbutrin XL.

In 2008, the FDA responded to complaints by assuring the public that the two drugs were pharmacologically equivalent. However, when the FDA first approved generic Wellbutrin, they only required a small study involving 25-35 people, to compare the lower-dose Wellbutrin and Budeprion. The studies only investigated the 150-mg doses — not 300-mg doses. The FDA assumed they could extrapolate data from the 150-mg study to the 300-mg dose.

Five years after the first complaints, the FDA finally conducted a study to check the time-release on Budeprion XL 300. They found similar results as the ConsumerLabs study.

The FDA has withdrawn approval of Budeprion XL 300 because it is not pharmacologically equivalent to Wellbutrin XL. Teva Pharmaceuticals has ceased shipments of the drug.


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