FDA Withdraws Approval of Generic Wellbutrin Because It Doesn't Perform Like the Brand Name DrugThe Wall Street Journal reports that the FDA has pulled the generic version of Wellbutrin from the shelves. The generic version of the popular antidepressant was yanked from shelves because tests found the generic drug doesn't work as well as the name brand drug. The highest strength of the pills, Budeprion XL 300 milligrams, is the drug affected.
The U.S. Food and Drug Administration said in a statement that the generic drug made by Impax and marketed by Teva, "is not therapeutically equivalent to Wellbutrin XL 300 mg." There are other generics on the market which are not affected by the FDA's withdrawal of approval of Teva's drug.
Wellbutrin XL lost patent protection in 2006 and the FDA approved the sale of generic versions of the drug. But after a round of complaints from patients, the FDA started looking into Teva's generic and found out that the correct does of the drug did not get into patients' bloodstreams. There is growing concern that generic drugs -- many of which are made in facilities outside the U.S. -- are not bioequivalent to the drugs they are supposed to replace. The inert ingredients in the drug can affect absorption of the active ingredient and affect how the drug works.
Posted on October 6, 2012