Fresenius Kabi Launches Generic Sugammadex in Simplist® Ready‑to‑Administer Prefilled Syringe in the U.S.

Product Launch

• Fresenius Kabi announced the U.S. launch of the FDA-approved generic Sugammadex Injection.
• Offering Sugammadex in a prefilled syringe further expands the use of the Simplist^® portfolio into operating rooms.
• Simplist^® single-dose, prefilled syringes require no assembly at the point of care, help streamline medication management, and eliminate steps where errors can occur.

LAKE ZURICH, Ill., September 3, 2026 - Fresenius Kabi, a global healthcare company part of the Fresenius Group, specializing in lifesaving therapies and technologies, today announced the U.S. launch of the FDA-approved generic Sugammadex Injection. Exclusivity for the branded medicine Bridion^® (Merck) expired in July 2026.

Fresenius Kabi offers operating room clinicians Sugammadex in a Simplist^® ready-to-administer prefilled syringe. Simplist^® single-dose, prefilled syringes require no assembly at the point of care, help streamline medication management, and eliminate steps where errors can occur.

Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery.

Fresenius Kabi offers Sugammadex in the following product presentation:

• 200 mg per 2 mL Simplist® prefilled syringe

"The opening of the Sugammadex market in the United States marks an important milestone for anesthesia teams and for patient access," said Joel Rosenstack, President, Pharmaceuticals, Fresenius Kabi USA. "As clinical demand for Sugammadex continues to grow, Fresenius Kabi's ready-to-administer prefilled syringe gives clinicians an option for more efficient medication management in the operating room with less risk for error."

More in America
Fresenius Kabi's Sugammadex products are filled, formulated, and packaged in the United States, reflecting the company's More in America commitment to strengthening domestic pharmaceutical manufacturing and enhancing supply-chain resiliency.

"Our U.S. production capabilities are central to ensuring reliable access to essential medicines," said Lindsey Thomas, Senior Vice President, Pharmaceutical Marketing. "Formulating, filling, and packaging Sugammadex in America underscores our long-standing investment in strengthening the U.S. supply chain and supporting the surgical teams who depend on these medicines every day."

As part of the Fresenius Group and its #FutureFresenius strategy, Fresenius Kabi is committed to strengthening healthcare resilience through reliable access to high-quality essential medicines. The launch of Sugammadex further enhances the company's U.S. pharmaceutical portfolio and supports healthcare providers in delivering safe and effective patient care.

Availability
Fresenius Kabi Sugammadex Injection products are available for ordering beginning today through Fresenius Kabi sales representatives or at (888) 386-1300. For full prescribing information, please consult the product labeling.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• Sugammadex Injection is contraindicated in patients with a known hypersensitivity to Sugammadex or any of its components.

WARNINGS AND PRECAUTIONS

• Anaphylaxis: Be prepared for hypersensitivity reactions (including anaphylactic reactions) and take necessary precautions.
• Marked Bradycardia: Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after administration. Monitor for hemodynamic changes and administer anticholinergic agents such as atropine if clinically significant bradycardia is observed.
• Respiratory Function Monitoring: Ventilatory support is mandatory until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured. Provide adequate ventilation if neuromuscular blockade persists after Sugammadex Injection or recurs following extubation.
• Waiting Times for Re-Administration of Neuromuscular Blocking Agents: If re-administration of neuromuscular blocking agent is required after reversal with Sugammadex Injection, waiting times should be based on the dose of Sugammadex Injection, and the renal function of the patient. Consider use of a nonsteroidal neuromuscular blocking agent.

ADVERSE REACTIONS

• Most common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg Sugammadex Injection dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache.
• Most common adverse reactions (reported in ≥10% of pediatric patients 2 to <17 years of age at Sugammadex Injection doses of 2 or 4 mg/kg) were pain, vomiting, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Toremifene: Concomitant use can delay recovery.
• Hormonal contraceptives: Patients must use an additional, non-hormonal method of contraception for 7 days following Sugammadex Injection administration.

USE IN SPECIFIC POPULATIONS

• Not recommended in patients with severe renal impairment.

INDICATIONS AND USE

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery.

Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION^® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.

This Important Safety Information does not include all the information needed to use Sugammadex Injection safely and effectively. Please see full prescribing information for Sugammadex Injection at www.fresenius-kabi.com/us."

About Fresenius Kabi

Fresenius Kabi is part of the global healthcare company Fresenius and specializes in lifesaving medicines, medical technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi's broad portfolio enables access to high-quality products across emergency medicine, surgery, oncology, intensive care, and at home - reaching around 450 million patients each year.

Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for the treatment of cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within medical nutrition; innovative medical technology including infusion pumps, cell and gene therapy devices, disposables and blood collection systems; and intravenous generic drugs and fluids that are vital to the work of healthcare providers globally.

For more information, please visit https://www.fresenius-kabi.com.

About Fresenius

Fresenius (XFRA: FRE, OTC: FSNUY) is a global, therapy-focused healthcare company dedicated to saving and improving human lives around the world. Through Fresenius Kabi and Fresenius Helios, the company delivers system-critical, innovative and affordable healthcare across the full continuum of care: Fresenius Kabi is a leading provider of lifesaving medicines, clinical nutrition, and medical technologies for critically and chronically ill patients, reaching around 450 million people each year. Fresenius Helios is Europe's largest private hospital operator, treating around 27 million patients annually.

With more than 178,000 employees and operating in more than 60 countries, Fresenius generated €22.6 billion in revenue in 2025.

For more information, visit  https://www.fresenius.com and follow Fresenius on LinkedIn.

Contact Information

For more information, please contact: Matthew Kuhn, tel:1-847-220-3033; [email protected]

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