The United States Court of Appeals for the Fourth Circuit issued an Order removing Mallinckrodt PLC (NYSE:MNK)’s pending litigation with the U.S. Food and Drug Administration (FDA) from the Court’s 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 Court’s calendar and that the litigation be allowed to proceed.
It remains Mallinckrodt Inc.’s position that its generic methylphenidate 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.
