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Posted October 2, 2008

FDA Permits Incorrect Labeling on Generic Wellbutrin XL, But May Require Drug to be Tested

The FDA has acknowledged inconsistencies in the labeling of Budeprion XL, a generic version of the antidepressant Wellbutrin XL, according to an October 2, 2008 article from Dow Jones News service.

As noted in the article, ConsumerLab.com's President, Tod Cooperman, brought the inconsistencies to the FDA's attention in July, hoping for corrections to be made.

ConsumerLab.com noted that statements in the package insert of the generic contradict information published by the FDA about the product. The insert claims that the product has been clinically tested, while the FDA has acknowledged that it has not. The insert states that food does not affect the absorption of drug, but the FDA has acknowledged that tests have not been done to support this. The insert states that the time to peak plasma concentration of the drug is about 5 hours, while the FDA has reported it to be 2 to 3 hours.

Suprisingly, despite the inconsistencies, an FDA spokeswoman told Dow Jones that the FDA considers the product to be "labeled appropriately." Apparently, the unsupported statements are copied from the package insert for the original Wellbutrin XL but, as explained by the spokeswoman, the labeling of a generic drug must match that of the drug it copies and this is "the standard" for all generics.

The article quotes ConsumerLab.com's Dr. Cooperman as saying "The rules clearly need to be changed to protect consumers."

A related article from the same news service on September 23, 2008 reported that the FDA may require further testing of Budeprion XL 300 mg to help the agency understand complaints about the product. Problems were originally reported by ConsumerLab.com and The People's Pharmacy in October, 2007, along with tests showing the generic to dissolve at a different rate than Wellbutrin XL.