DUBLIN, Jan. 24, 2018 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that it has agreedto a request by the U.S. Food and Drug Administration (FDA) to seek a temporary stay of the litigation initiated against FDA in October 2017 by the Company's subsidiaries, Par Sterile Products, LLC and Endo Par Innovation
"Endo brought this lawsuit because FDA violated the DQSA by issuing an improper 'Interim Policy' and by listing vasopressin as a 'Category 1' substance that outsourcing facilities could use in bulk compounding under Section 503B. FDA's recent public statements indicate that it is now taking steps to comply with the DQSA and that it plans to announce further details by the end of March 2018. Those statements, in conjunction with subsequent discussions among the parties' counsel, have led Endo to conclude that a temporary stay of its litigation against FDA is appropriate and therefore agree to FDA's request," said Matthew J. Maletta, Executive Vice President and Chief Legal Officer of Endo. In its recently issued 2018 Compounding Policy Priorities Plan, FDA explains that:
"We look forward to continuing our dialog with FDA," said Mr. Maletta, "and we are hopeful that the policy changes FDA has described, once effective, will address the multiple concerns that led Endo to file this case."
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
Cautionary Note Regarding Forward-Looking Statements
Certain information in this press release may be considered "forward-looking statements," including, but not limited to, the statements by Mr. Maletta. All forward-looking statements in this press release reflect Endo's current expectations of future events based on information available to Endo as of the date of this press release. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo's expectations and projections. Risks and uncertainties include, among other things, general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; the outcome of litigation, settlement discussions or other adverse proceedings; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Endo's periodic reports filed with the U.S. Securities and Exchange Commission and in Canada on the System for Electronic Data Analysis and Retrieval ("SEDAR"), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K.
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SOURCE Endo International plc
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