Teva’s Generic Bupropion XL Meets Bioequivalence To Wellbutrin XL, FDA Finds
This article was originally published in The Pink Sheet Daily
Reported loss of antidepressant effect likely owed to natural disease progression, agency says.
You may also be interested in...
In what appears to the first downgrade of a generic equivalency based on patient complaints, FDA changes the high dose of the Teva/Impax product from AB to BX. The four other generic manufacturers of 300 mg bupropion extended-release must conduct their own bioequivalence tests, but FDA does not expect problems because they are differently formulated than the Teva/Impax version.
The public’s acceptance of generic drugs is at an all-time high. But manufacturing issues, shortages of life-saving medications and questions about the overall quality of generics are testing the system like never before. FDA’s tough love message to industry: fix the manufacturing problems—or risk your reputation.
"Complete response" letter from FDA should be addressed by the end of the year, firms state.