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FDA Proposes to Withdraw Approval for Generic ADHD Drugs

October 19, 2016

The US Food and Drug Administration (FDA) recently announced its proposal to withdraw approval of two generic attention-deficit hyperactivity disorder drugs—versions of Jannsen's Concerta (methylphenidate hydrochloride) extended-release capsules.

According to the FDA announcement, generic drug manufacturers Mallinckrodt Pharmaceuticals and UCB/Kremers Urban (formerly known as Kudco) have “failed to demonstrate that their products provide the same therapeutic effect as (are bioequivalent to) the brand-name drug they reference.”
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In November 2014, the FDA voiced concerns over whether the two generic drugs, which were already approved at the time, were therapeutically equivalent to Concerta (manufactured by Janssen). Mallinckrodt and Kudco were given the choice to either voluntarily withdraw their drugs from the market and ask that the FDA withdraw approval of their drugs’ Abbreviated New Drug Applications or provide data within 6 months proving that their generic drugs are bioequivalent to the brand name drug.

The FDA’s suggestion to withdraw approval of the drugs stems from the fact that neither company completed either of the steps proposed back in 2014.

Mallinckrodt and UCB/Kremers Urban may request a hearing to demonstrate why FDA approval should not be withdrawn. “Each firm must respond in writing, within 30 days, to request a hearing. If the firm fails to do so, the opportunity for a hearing will be waived,” as written in the FDA announcement.

In the meantime, the two generic drugs are still approved and, therefore, can still be prescribed, but the FDA points out that “they are not recommended as automatically substitutable for Concerta.”

—Meredith Edwards White



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