Theophylline

LAKE ZURICH, Ill. & RICHMOND, Va.--(BUSINESS WIRE)--Fresenius Kabi and Phlow Corp. announced today a first-of-its-kind collaboration to onshore the manufacture of Epinephrine Injection, USP, an essential medicine long at risk of chronic shortage in the U.S. and widely used in hospitals nationwide. Fresenius Kabi and Phlow announce first-of-its-kind collaboration to onshore the manufacture of Epinephrine Injection, USP, an essential medicine long at risk of chronic shortage in the U.S. and widely used in hospitals nationwide. The arrangement, which includes the domestic manufacture of active pharmaceutical ingredients (APIs) and finished doses, is designed to be scalable to other essential medicines. Under the agreement, Phlow will produce the API for Epinephrine Injection, USP, and Fresenius Kabi will perform the formulation and production of finished doses for hospitals and clinics. Phlow recently completed a successful U.S.-based validation campaign for epinephrine API and filed a Drug Master File (DMF) with FDA, positioning it as the emerging domestic source for onshoring API production. Epinephrine injection is considered an essential medicine by the U.S. Food and Drug Administration and the World Health Organization. It is a lifesaving drug, indicated for emergency treatment of allergic reactions, including anaphylaxis, in adults and pediatric patients. It is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. While Fresenius Kabi has been producing Epinephrine Injection, USP in the U.S., there is no domestic source for epinephrine API today. “Fresenius is a committed partner in advancing America’s vision of a fully domestic, end-to-end, supply chain for essential medicines, closing a vital gap in national security,” said Joel Rosenstack, President U.S. Pharmaceuticals, Fresenius Kabi. “Phlow is pioneering bold solutions to restore pharmaceutical sovereignty and strengthen America’s national health security,” said Eric Edwards, M.D., Ph.D., CEO of Phlow. “For several years, we have worked alongside Fresenius Kabi to build resilient, end-to-end supply assurance for essential medicines. This expanded collaboration is focused on securing a reliable domestic supply of epinephrine, one of the most critical, life-saving drugs used across emergency and acute care settings in the United States.” Fresenius Kabi, an operating company of the Fresenius group, is a global leader in injectable medicines, biosimilars, clinical nutrition, and medical technologies. It is the nation’s leading manufacturer of generic injectable medicines and offers more than 70 percent of the medicines designated as essential by the FDA. As part of its local-for-local strategy, Fresenius Kabi produces more than 70 percent of the medicines it sells in the U.S. in state-of-the-art production centers in Illinois, New York and North Carolina. The company has invested more than $1 billion to stand up modern domestic pharmaceutical manufacturing and logistics centers. To learn more about these initiatives, please visit www.moreinamerica.com. Phlow is a leading American advanced pharmaceutical contract development and manufacturing organization with a state-of-the-art advanced manufacturing campus in Virginia, including facilities in Richmond and Petersburg, that produces APIs and other pharmaceutical products. Learn more at www.phlow-usa.com. Pending FDA and other necessary approvals, Epinephrine Injection, USP produced under this agreement could be available to U.S. hospitals in 2027. About Phlow Corp. Phlow, a B Corporation™, helps brilliant minds bring medicines to life through advanced development and manufacturing in America. Focused on innovations in drug substance development, Phlow supports government and private industry customers to create innovative approaches with scientific expertise, world-class manufacturing, and tech-enabled processes that propel the industry forward to a new standard as we create the future of how medicines are made. As a modern contract development and manufacturing provider, we measure our impact by increasing speed to market, reducing waste, and offering an environmentally friendly approach to manufacturing medicines that lead to healthy, resilient communities. For more, visit phlow-usa.com. About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. Epinephrine Injection, USP Important Safety Information WARNINGS AND PRECAUTIONS Do not inject into buttocks, digits, hands, or feet. Avoid extravasation into tissues, which can cause local necrosis. Monitor patient for acute severe hypertension. Potential for pulmonary edema, which may be fatal. May constrict renal blood vessels and decrease urine formation. May induce potentially serious cardiac arrhythmias or aggravate angina pectoris, particularly in patients with underlying heart disease. Presence of sulfite in this product should not deter use. ADVERSE REACTIONS Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. 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 Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, ergot alkaloids, and phenothiazine antipsychotics. Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin. Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, quinidine, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for development of cardiac arrhythmias. Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. INDICATIONS AND USAGE Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients. To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. This Important Safety Information does not include all the information needed to use Epinephrine Injection, USP safely and effectively. Please see full prescribing information for Epinephrine Injection, USP at www.fresenius-kabi.com/us.

Endo adds ADRENALIN® premixed IV bags in concentrations of 2 mg, 5 mg, and 10 mg per 250 mL. Endo now offers ADRENALIN® premixed IV bags in five of the most used concentrations, including the 5 mg and 10 mg which align with ASHP's Standardize 4 Safety Initiative Endo's products are the first FDA-approved, commercially available manufacturer-prepared epinephrine premixed intravenous (IV) bag. MALVERN, Pa., Sept. 23, 2025 /PRNewswire/ -- Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today the launch of ADRENALIN® (epinephrine in 0.9% sodium chloride injection) premixed IV bags in three new concentrations: 2 mg/250 mL, 5 mg/250 mL (20 mcg/mL), and 10 mg/250 mL (40 mcg/mL). With this launch, Endo expands its ADRENALIN® portfolio to include premixed IV bags in five concentrations: 2 mg, 4 mg, 5 mg, 8 mg, and 10 mg per 250 mL. The portfolio also includes ADRENALIN® (epinephrine injection, USP) in 1 mL single-dose and 30 mL multi-dose vials. The 5 mg/250 mL and 10 mg/250 mL concentrations align with the American Society of Health-System Pharmacists (ASHP) Standardize 4 Safety Initiative, supporting efforts to reduce medication errors and enhance patient safety. ADRENALIN® is the first FDA-approved, commercially available manufacturer-prepared epinephrine premixed IV bag, offering healthcare providers a ready-to-use solution that supports streamlined care delivery. "We're proud to support hospital teams with ready-to-use medicines that help make care easier and more efficient," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions and Generics. "We're excited to grow our TruDelivery® portfolio and give providers more options to focus on what matters most–caring for patients." Key product benefits include: No compounding or preparation required Single-port IV tubing to reduce the risk of inadvertent mixture 24-month shelf life at room temperature ADRENALIN® premixed IV bag is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. The ADRENALIN® premixed IV bag is part of Endo's TruDelivery® product line and platform. Ready-to-use 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 ASHP and Standardize 4 Safety Initiative ASHP, the largest association of pharmacy professionals in the U.S., received funding from the FDA's Safe Use Initiative to develop and implement national standardized concentrations for intravenous (IV) and oral liquid medications. This effort led to the creation of Standardize 4 Safety, the first national, interprofessional initiative aimed at reducing medication errors—especially during transitions of care. Developed in collaboration with pharmacists, nurses, and physicians across the care continuum, the initiative provides standardized concentration lists for patients of all ages in settings from hospital to home. Hospitals and health systems are encouraged to adopt these lists to enhance safety and reduce errors. Additional lists are forthcoming, and professionals can register with ASHP to receive updates. For more information, visit ashp.org. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When ADRENALIN® premixed IV bag is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein. Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. ADVERSE REACTIONS: Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. DRUG INTERACTIONS: Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids. Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias. Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. USE IN SPECIFIC POPULATIONS: Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Click for Full Prescribing Information. About Endo Endo, a wholly owned subsidiary of Mallinckrodt plc, is a diversified therapeutics manufacturer boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This release contains forward-looking statements, including with regard to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with our products; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Endo's and Mallinckrodt's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website () and Mallinckrodt's website (). The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. SOURCE Endo USA, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED