Teva's High-Dose Generic Wellbutrin XLWithdrawn
Teva's High-Dose Generic Wellbutrin XLWithdrawn
Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
The FDA action comes five years after patients complained of headaches and returning depression after switching from brand-name Wellbutrin XL to Teva's generic version. The Teva generic was approved in December 2006.
In 2009, the FDA wrongly assured patients that the Teva generic worked just as well as the name brand. But it wasn't until 2010 that the FDA finally decided to test the full-dose version of the drug. Those tests, completed just weeks ago, found that instead of proper extended release, Teva's drug dumped too much active ingredient too soon and failed to maintain effective drug levels.
The FDA tests in people finally came to the same conclusion as October 2007 lab tests by Tod Cooperman, MD. Cooperman's for-profit company, the ConsumerLab web site, tests nutritional supplements and generic drugs for potency and accurate labeling.
"The generic did not act like a once-a-day formula but more like an immediate-release formula," Cooperman says.
Teva and Impax Laboratories, which makes the drug for Teva, have recalled the drug. The lower-dose version, Budeprion XL 150 mg, remains on the market. FDA's waived tests of the now-withdrawn 300-mg version of the drug based on tests of the lower-dose version -- a process called "waiving up."
The FDA defended the practice, noting that generic drugs are tested on small numbers of healthy volunteers to see if they work the same as (are "bioequivalent" to) brand-name drugs. The agency was reluctant to expose these volunteers to the side effects of the higher-dose drug.
"A less cautious approach in studying the bioequivalencies of Budeprion XL 300 mg could have brought the data to light earlier," the FDA admits on its web site.
Four other companies make generic, extended-release versions of Wellbutrin XL 300 mg: Anchen, Watson, Actavis, and Mylan.
However, the FDA has asked each of these manufacturers to test the drugs at full dose to see if they truly are the same as the brand-name antidepressant.
It's likely they are. Most of the complaints received by the FDA concerned the Teva/Impax drug.
High-Dose Generic Wellbutrin XL Withdrawn
Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
The FDA action comes five years after patients complained of headaches and returning depression after switching from brand-name Wellbutrin XL to Teva's generic version. The Teva generic was approved in December 2006.
In 2009, the FDA wrongly assured patients that the Teva generic worked just as well as the name brand. But it wasn't until 2010 that the FDA finally decided to test the full-dose version of the drug. Those tests, completed just weeks ago, found that instead of proper extended release, Teva's drug dumped too much active ingredient too soon and failed to maintain effective drug levels.
The FDA tests in people finally came to the same conclusion as October 2007 lab tests by Tod Cooperman, MD. Cooperman's for-profit company, the ConsumerLab web site, tests nutritional supplements and generic drugs for potency and accurate labeling.
"The generic did not act like a once-a-day formula but more like an immediate-release formula," Cooperman says.
Teva and Impax Laboratories, which makes the drug for Teva, have recalled the drug. The lower-dose version, Budeprion XL 150 mg, remains on the market. FDA's waived tests of the now-withdrawn 300-mg version of the drug based on tests of the lower-dose version -- a process called "waiving up."
The FDA defended the practice, noting that generic drugs are tested on small numbers of healthy volunteers to see if they work the same as (are "bioequivalent" to) brand-name drugs. The agency was reluctant to expose these volunteers to the side effects of the higher-dose drug.
"A less cautious approach in studying the bioequivalencies of Budeprion XL 300 mg could have brought the data to light earlier," the FDA admits on its web site.
Alternative Generic Wellbutrin Products
Four other companies make generic, extended-release versions of Wellbutrin XL 300 mg: Anchen, Watson, Actavis, and Mylan.
However, the FDA has asked each of these manufacturers to test the drugs at full dose to see if they truly are the same as the brand-name antidepressant.
It's likely they are. Most of the complaints received by the FDA concerned the Teva/Impax drug.