On October 21, 2016, the United States Court of Appeals for the Fourth Circuit issued an Order removing Mallinckrodt Inc.s pending litigation with the U.S. Food and Drug Administration (FDA) from the Courts oral argument calendar and placing that litigation in abeyance pending the outcome of the Approval Withdrawal Proceedings initiated by the FDA on October 17, 2016. In response, on October 21, 2016, Mallinckrodt Inc. filed a Motion to Reconsider with the Court requesting that the oral arguments be placed back on the Courts calendar and that the litigation be allowed to proceed. On October 24, 2016, the Court affirmed its earlier decision and stayed the litigation pending the outcome of FDAs Approval Withdrawal Proceedings.
It remains Mallinckrodt Inc.s position that its generic m ethylphenidate ER product is a safe and effective treatment option for patients who suffer from ADHD. As such, Mallinckrodt Inc. plans to vigorously set forth its position in the Approval Withdrawal Proceedings and is exploring additional options regarding this matter.
The information furnished pursuant to Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed filed under the Securities Exchange Act of 1934, as amended (the Exchange Act), nor shall it be incorporated by reference into any filings by the Company under the Securities Act of 1933, as amended (the Securities Act) or under the Exchange Act, except as expressly set forth by specific reference in such a filing. The furnishing of information pursuant to this Item 7.01 will not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely by Regulation FD.
Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MALLINCKRODT PUBLIC LIMITED COMPANY
October 24, 2016
/s/ Kenneth L. Wagner
Kenneth L. Wagner
Vice President and Corporate Secretary
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