FDA pulls Teva’s generic Wellbutrin for working improperly
Teva Pharmaceuticals has stopped shipping its generic version of Wellbutrin XL 300 after a federal analysis found the antidepressant does not work in the same way the brand name drug does. Drug regulators discovered that Teva’s generic Wellbutrin XL 300, known by the name Budeprion, releases its key ingredient faster than the brand name Wellbutrin XL 300, which is made by GlaxoSmithKline.
Generic drugs are ones that are comparable to brand-name drugs in dosage, strength, route of administration, quality and performance characteristics, and intended use. Generic drugs must contain the same active ingredients as the original formulation. Both Wellbutrin XL and Buderprion XL are available in 150 mg and 300 mg tablets.
In 2007, the website ConsumerLab published an analysis of Wellbutrin XL and Teva’s Budeprion XL and found that the generic drug released 34 percent of its active ingredient in just two hours, compared to eight percent for the brand name drug.
In 2008, hundreds of patients complained that Budeprion not working as well as Wellbutrin or caused side effects such as headaches, anxiety and insomnia. The Food and Drug Administration (FDA) reviewed tests on the 150 mg tablets of Budepron under the assumption that the results would also apply to the 300 mg version. The agency concluded that Wellbutrin XL and Budeprion are essentially the same.
Now the FDA says that assuming the 300 mg version of Budeprion would work the same as the 150 mg pill is “no longer appropriate.” After more complains were received, the FDA conducted a study of its own and informed Teva of the substandard results last month.
Drug makers Anchen, Actavis, Watson and Mylan also manufacture generic versions of Wellbutrin. The FDA has not tested other generics of the drug but has asked the drug makers to conduct their own studies and submit the results to the agency by March 2013.