Mallinckrodt (MNK) Announces Court Affirmation to Stay Litigation Pending FDA’s Approval Withdrawal Proceedings Outcome

October 24, 2016 4:52 PM EDT

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Mallinckrodt (NYSE: MNK) disclosed the following in a U.S. SEC filing on Monday:

Item 7.01 Regulation FD Disclosure

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 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. On October 24, 2016, the Court affirmed its earlier decision and stayed the litigation pending the outcome of FDA’s Approval Withdrawal Proceedings.

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.



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