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Updated Mallinckrodt Statement on Extended-Release Methylphenidate Tablets

Feb. 21, 2017

At the request of the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), the FDA Commissioner has agreed to suspend the deadline for submitting documentation in support of a hearing on the FDA's proposal to withdraw Mallinckrodt's Abbreviated New Drug Application for its Extended-Release Methylphenidate Tablets. No new deadline has been set at this time. This information was conveyed to Mallinckrodt in a letter received today.

Mallinckrodt appreciates the FDA's willingness to provide the company with FDA documents related to this matter. In addition, Mallinckrodt agrees with the FDA that additional time will be needed to appropriately review those documents, and appreciates the FDA's willingness to adjust the timeline to ensure sufficient review and preparation time while continuing to expeditiously advance the process.

It remains Mallinckrodt's position that its generic methylphenidate ER products are safe and effective treatment options for patients who suffer from attention-deficit and hyperactivity disorder.

CONTACTS
  Investor Relations
  Coleman N. Lannum, CFA
  Senior Vice President, Investor Strategy and IRO
  314-654-6649
  cole.lannum@mallinckrodt.com

Daniel J. Speciale, CPA
  Director, Investor Relations
  314-654-3638
  daniel.speciale@mallinckrodt.com

Media
  Rhonda Sciarra
  Senior Communications Manager
  908-238-6765
  rhonda.sciarra@mallinckrodt.com

Meredith Fischer
  Chief Public Affairs Officer
  314-654-3318
  meredith.fischer@mallinckrodt.com