Texas Budeprion XL 300 LawyerOctober 5, 2012 — After years of consumer complaints that generic Wellbutrin XL (sold as Budeprion XL 300-mg) is different than brand-name Wellbutrin XL and has more serious side effects, the U.S. Food and Drug Administration (FDA) has withdrawn approval of the generic drug. In an unusual circumstance, the patent on brand-name Wellbutrin XL expired, but not the patent on its special time-release mechanism. This was not disclosed to consumers. Ultimately, independent studies found that generic Budeprion XL 300 released the active ingredients much faster than brand-name Wellbutrin XL — a difference that has allegedly caused some patients severe headaches, recurrent depression, insomnia, anxiety, and other side effects.

 

The FDA has published new Drug Safety Information to announce that Budeprion XL 300 mg is not therapeutically equivalent to Wellbutrin XL 300. The FDA conducted tests that found Budeprion XL 300 does not properly release its active ingredients. They have withdrawn approval for the drug.

In 2008, the FDA insisted that the two drugs were essentially equivalent, despite the fact they they had received hundreds of complaints from people who suffered headaches, anxiety, insomnia, and recurrent depression after switching from brand-name to generic.

Consumer advocacy groups are mostly responsible for raising awareness about the issue. ConsumerLabs, a for-profit organization that tests dietary supplements and pharmaceutical drugs, published a report in 2007 showing that Budeprion released its active ingredients much faster than Wellbutrin. The FDA’s study has confirmed this conclusion. Teva Pharmaceuticals, the company that sells Budeprion XL 300, has stopped shipments of the drug in response to the FDA’s actions.

When the FDA approves generic medications, they typically require only small sample studies, involving only 25 or 35 people, to prove that the generic drug is equivalent to the brand-name drug. When the FDA approved Budeprion, they only required a test of the 150-mg dose of the drug — not the 300-mg dose — because they assumed they could extrapolate data from the 150-mg study.

The FDA will now require generic drug companies to submit tests of high-dose generic drugs in addition to the lower-dose to prove that they are absorbed at the same rate as the brand-name medication.

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