The world’s largest maker of generic drugs, Teva Pharmaceuticals has announced it agreed to yank its entire generic version of Wellbutrin XL from pharmacies and store shelves across the United States. Teva’s decision followed a report from the U.S. Food and Drug Administration that said the medication was not a good enough match for the original form of the drug.
The FDA took a step that was very unusual for the U.S. regulatory agency. The FDA acknowledged that the very popular generic version of Wellbutrin XL, an antidepressant, was not adequately equivalent to the original drug that GlaxoSmithKline has sold since 2003.
The FDA’s move prompted Teva, which is based in Israel, to stop all shipping of bupropion in its extended release formula. The medication is known commercially as Budeprion. Teva also announced the drug would be taken off all shelves throughout the U.S.
The announcement by the U.S. regulatory agency was a 180-degree turn from before when in 2009 the agency declared the generic version was bioequivalent and equivalent therapeutically with the brand name drug Wellbutrin XL. The 2009 announcement came in response to many concerns voiced by the public over the medication.
This week’s FDA announcement might start a number of questions to be raised as to other generic drugs and their effectiveness compared to their more expensive originals. Recently a number of pharmacologists have started to question the standards set by the FDA for approving the many different medications that are generic.