Endo Announces Launch of Ready-to-Use VASOSTRICT® (vasopressin injection, USP) in Pre-Mix Bottles

Rhea-AI Summary

Endo International plc has launched VASOSTRICT®, the first FDA-approved ready-to-use vasopressin injection in 100 mL pre-mix bottles. This product eliminates the need for preparation, potentially reducing waste and preparation errors, thereby enhancing patient care. VASOSTRICT® offers a two-year shelf life, with up to 12 months at room temperature, which can improve inventory management for healthcare providers. The product aims to streamline operations in hospitals and comply with safety standards.

Positive

• First FDA-approved ready-to-use vasopressin formulation enhances patient care.
• Eliminates preparation errors, reducing waste and costs for healthcare providers.
• Two-year shelf life and room temperature stability improve inventory management.

Negative

• None.

DUBLIN, Feb. 7, 2022 /PRNewswire/ --

• First and only manufacturer-prepared, FDA approved vasopressin in a premixed ready-to-use (RTU) format
• RTU format does not require diluting, or transferring, which may reduce waste and chance of preparation error that could impact a patient's health
• Two-year shelf life¹, with up to 12 months at room temperature²*, may offer enhanced health systems' inventory management

Endo International plc (NASDAQ: ENDP) announced today that its Par Sterile Products business has begun shipping VASOSTRICT^®, vasopressin injection, USP, in ready-to-use 100 mL pre-mix bottles. It's the first and only ready-to-use formulation of the drug.

"Our partners in healthcare are working harder than ever; this new ready-to-use bottle allows them to focus more of their time on what matters most—patient care," said Scott Sims, Senior Vice President and General Manager, Sterile Products at Endo. "Our team remains dedicated to meeting the evolving needs of healthcare providers."

Ready-to-use, or RTU, products help 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 heighten accuracy and compliance by reducing the chance for preparation error—all of which support quality patient care.

This new VASOSTRICT^® formulation has a two-year shelf life¹, with up to 12 months at room temperature²*, which may offer enhanced inventory management in addition to the other advantages of an RTU formulation/presentation.

* Store between 2°C and 8°C (36°F and 46°F). Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions (20°C to 25°C [68°F to 77°F]).

About Endo
Endo (NASDAQ: ENDP) 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 the best 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.

About Par Pharmaceutical
Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses an expanding portfolio that includes sterile injectables, alternative dosage forms and other differentiated products. Par Pharmaceutical is an Endo company. Learn more at www.parpharm.com.

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 and any statements relating to product launch, shipments, quality, safety or reductions in cost or waste. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this press release reflect Endo's current expectations of future events based on existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, contingency planning and any potential restructuring; the timing, impact or results of any pending or future litigation, investigations or claims or actual or contingent liabilities, settlement discussions, negotiations or other adverse proceedings; our ability to satisfy judgments or settlements or pursue appeals including bonding requirements; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our inability to maintain compliance with financial covenants and operating obligations which would expose us to potential events of default under our outstanding indebtedness; our ability to incur additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes; our ability to refinance our indebtedness; a significant reduction in our short-term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs or repay indebtedness. The occurrence or possibility of any such result has caused us to engage, and may result in further engagement in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential corporate reorganization, restructuring or bankruptcy filing involving all or a portion of our business, asset sales or other divestitures, cost-saving initiatives, corporate realignments or strategic partnerships. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission.

References:

1. Data on File. Vasostrict^® Stability Summary Report. Par Sterile Products, LLC; December 8, 2021.
2. Vasostrict^® Prescribing Information 04/2021.

View original content to download multimedia:https://www.prnewswire.com/news-releases/endo-announces-launch-of-ready-to-use-vasostrict-vasopressin-injection-usp-in-pre-mix-bottles-301476236.html

SOURCE Endo International plc

FAQ

What is VASOSTRICT® launched by Endo?

VASOSTRICT® is the first FDA-approved ready-to-use vasopressin injection offered in 100 mL pre-mix bottles.

How does VASOSTRICT® improve patient care?

VASOSTRICT® streamlines operations by eliminating the need for preparation, reducing waste and the risk of errors in patient care.

What is the shelf life of VASOSTRICT®?

VASOSTRICT® has a two-year shelf life, with up to 12 months at room temperature.

How does the new formulation impact healthcare providers?

The new ready-to-use formulation helps healthcare providers focus more on patient care by simplifying the administration process.

When was VASOSTRICT® announced?

VASOSTRICT® was announced on February 7, 2022, by Endo International plc.