FDA Announcement on Generic Concerta Products

Since CADDAC continues to receive feedback from our stakeholders about reduced symptom coverage and/or increased side effects they are experiencing with the generic forms of Concerta available in Canada we are keeping you updated on what is occurring south of the border and in Canada on this issue.

You may remember that in the fall of 2014 the US Food and Drug Administration (FDA) determined that two generic versions of Concerta one manufactured by Mallinckrodt Pharmaceuticals and the other by Kudco would be downgraded. This meant the Mallinckrodt and Kudco products were still approved and could be prescribed, but were no longer recommended to be automatically substituted for Concerta by a pharmacist. These medications are not available here in Canada, but we do have different generic versions of Concerta here that have been approved for direct substitution and remain so.

Recently, the FDA announced that “Neither Mallinckrodt nor UCB/Kremers Urban has voluntarily withdrawn its product from the market, and neither has provided data confirming its product’s bioequivalence consistent with the revised recommendations.  Accordingly, the FDA is proposing to withdraw approval of the products’ ANDAs and is announcing an opportunity for the firms to request a hearing on the proposal.  As part of this process, the FDA is publishing Notices of Opportunity for Hearing (NOOHs) on its Proposals to Withdraw Marketing Approval in the Federal Register. If approval of these ANDAs is withdrawn by the FDA, the products will no longer be able to be marketed in the U.S.”

I will be meeting with Health Canada next week to share  feedback that CADDAC has received through our past parent/adult surveys and the e-mails, calls and discussions with our stakeholders.

After our meeting I will up-date you on any feedback that we receive during the meeting or any decisions made by Health Canada.   

Access the full FDA announcement HERE

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