On September 28, 2018, Egalet Corporation 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. The Company tests its intangible and long-lived assets for impairment annually or more frequently if events or circumstances indicate that there may be impairment. The Discontinuation may result in indications of potential impairment of certain assets related to ARYMO ER. Consequently, in connection with the preparation and review of the Company’s financial statements for the third quarter of fiscal 2018, the Company intends to perform an interim evaluation of its intangible and long-lived assets for possible impairment, although the Company is not certain whether it will complete the testing procedures in time to incorporate the related results into its financial statements for such quarter. The analysis may result in the Company incurring a charge to impair its intangible or long-lived assets.