FDA expresses confidence in reviews of generic drugs

12/6/2012 | Medscape (free registration)

The FDA's approval process for generic drugs, including approvals based on extrapolated data, is safe and reliable, Center for Drug Evaluation and Research Director Dr. Janet Woodcock and other FDA officials wrote in an article in the New England Journal of Medicine. The agency withdrew approval for 300-mg bupropion after finding it did not perform similarly to the brand-name version of the same dose. The drug was approved based on extrapolation of bioequivalence data from the 150-mg dose.

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