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Glen Elliott, MD, PhD
Editor-in-chief, The Carlat Child Psychiatry Report
In November 2016, the FDA announced that it was requiring two companies to withdraw their generic versions of Concerta (OROS methylphenidate) because of efficacy concerns. Such actions are quite unusual, and when they occur, they tend to shake doctors’ confidence in the generic drug system—which branded drug companies are often eager to encourage. But the Concerta case is hardly an indictment of generic drugs, or even of generic stimulants. Let’s dig a little deeper for some insight into the generic drug process.