The Food and Drug Administration (FDA) announced a proposal to withdraw the approval of two generic versions of Concerta (methylphenidate HCl; Janssen) extended-release capsules indicated for attention-deficit hyperactivity disorder (ADHD).  

The companies Mallinckrodt and UCB/Kremers Urban (formerly Kudco) failed to demonstrate that their generic products were bioequivalent to the brand-name reference product. 

After a data analysis in November 2014, the FDA expressed concerns that the Mallinckrodt and Kudco products may not provide the same therapeutic effects as Concerta. The Companies were requested to take either of the following steps:

  1. Voluntarily withdraw their products from the market and request the FDA withdraw approval of their respective Abbreviated New Drug Application (ANDAs); or 
  2. Within 6 months, provide data to confirm that their products were bioequivalent to Concerta consistent with the revised draft guidance for industry for bioequivalence testing for these products 

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At that time, the FDA also modified the Orange Book therapeutic equivalence code for these two products from AB (therapeutic equivalence) to BX (data are insufficient to determine therapeutic equivalence). 

Because Mallinckrodt and UCB/Kremers Urban have neither voluntarily withdrawn their products or provided bioequivalence data consistent with revised recommendations, the FDA has proposed to withdraw approval of the products’ ANDAs. In addition, the FDA has announced an opportunity for the firms to request a hearing on the proposal. 

The FDA is publishing Notices of Opportunity for Hearing (NOOHs) on its Proposals to to Withdraw Marketing Approval in the Federal Register. Each NOOH details how the firm may request a hearing to demonstrate why their ANDA approval should not be withdrawn. If both companies fail to respond and request a hearing within 30 days, the opportunity for a hearing will be waived.

The Agency will also update the related Mallinckrodt and UCB/Kremers Urban dockets as new data becomes available.

Healthcare professionals who have patients on these generic products and have concerns about lack of desired effect should consider using a different product. 

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