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.
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
Daniel J. Speciale, CPA
Director, Investor Relations
Senior Communications Manager
Chief Public Affairs Officer