On September 28, 2018, Egalet Corporation (the “Company”) notified the U.S. Food and Drug Administration that, for business reasons, the Company is discontinuing the manufacture and promotion of Arymo® ER (morphine sulfate) extended-release tablets (“ARYMO ER”) effective September 28, 2018 (the “Discontinuation”). As part of its notice, the Company requested that the Orange Book staff move ARYMO ER to the “Discontinued Drug Products List” of the Approved Drug Products and Therapeutic Equivalence Evaluations (Orange Book) publication, and that the User Fee staff note the discontinued status of the product.
