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FDA Follow-Up Finds Another Generic Bupropion Fails Bioequivalence Test

The Food and Drug Administration has issued a long-awaited report on the quality of a generic antidepressant. Last October the FDA reported that one generic form of the drug Wellbutrin did not meet its bioequivalence standards. This long-acting form of bupropion was unceremoniously pulled off the market. This was the first time in recent memory that a generic medication approved by the FDA was later determined to be inadequate.

At that time the FDA required all generic forms of the long-acting 300 mg formulation to be tested to see if they were identical to the brand name Wellbutrin. While products from Mylan, Actavis and Par were acceptable, the Watson form was deemed not therapeutically equivalent to Wellbutrin XL 300. The drug will be voluntarily withdrawn. 

[FDA, Oct. 10, 2013]

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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