Endo Launches PREVDUO™ (neostigmine methylsulfate and glycopyrrolate injection), the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination Pre-Filled Syringe

• The ready-to-use pre-filled syringe combines two well-known, FDA-approved products in a standard concentration ratio
• Product eliminates the need for two discrete syringe preparations and administrations, which helps increase efficiency for hospitals and healthcare providers

DUBLIN, June 12, 2023 /CNW/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping PREVDUO^™ (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe, the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S.

"This is the latest way we're addressing operational and clinical challenges in order to support patient care," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "With two medications in one ready-to-use syringe, PREVDUO^™ reduces complexity and increases efficiency for hospitals and healthcare providers."

Both neostigmine methylsulfate and glycopyrrolate have been approved in the U.S. as single, active ingredient drug products. Neostigmine is always administered in conjunction with glycopyrrolate and, until now, its administration has required two syringes.

In April, Endo executed an agreement with Slayback Pharma LLC to distribute PREVDUO^™ on an exclusive basis in the U.S.

Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care.

About Endo

Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Sims, any statements relating to product launch, commercialization, sales, supply or distribution, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law.

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SOURCE Endo International plc

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