Metoclopramide Hydrochloride

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced two new products in its Simplist® portfolio of ready-to-administer prefilled syringes: Simplist® Ephedrine Sulfate Injection, USP and Simplist® Succinylcholine Chloride Injection, USP. Both medications are used in anesthesia and critical care, and their introduction extends the Simplist line’s use into operating rooms, supporting clinicians with safe, efficient and reliable medication delivery. Fresenius Kabi has expanded its Simplist® ready-to-administer portfolio, introducing new presentations that extend its use into operating rooms and support clinicians in anesthesia and critical care. Simplist Succinylcholine Chloride Injection, USP, is a paralytic used in addition to general anesthesia for intubation and during mechanical ventilation in pediatric and adult patients. Simplist Ephedrine Sulfate Injection, USP is indicated for the treatment of clinically important hypotension (low blood pressure) during anesthesia. “As part of our commitment to simplify medication delivery and improve patient safety, the expansion of our Simplist portfolio into the operating room demonstrates how we’re supporting anesthesiologists and nurse anesthetists in their vital work,” said Arun Verma, president of Fresenius Kabi Region U.S. and member of the Executive Leadership Team at Fresenius Kabi AG. “These ready-to-administer medications are designed to help clinicians throughout the hospital by helping to reduce complexity, help minimize waste, and reduce the number of drug-preparation steps where errors can occur.” About the Products: Simplist Succinylcholine Chloride Injection, USP is available in 100 mg per 5 mL (20 mg per mL) and 200 mg per 10 mL (20 mg per mL) strengths. It offers an 18-month shelf life and is stored in a refrigerator at 36°F (2°C) to 46°F (8°C). The single dose prefilled syringes are stable for up to 14 days at room temperature without loss of potency. Simplist Ephedrine Sulfate Injection, USP is available in 25 mg per 5 mL (5 mg per mL) and 50 mg per 10 mL (5 mg per mL) presentations. It can be stored at room temperature and has a 24-month shelf life. Both prefilled syringes are manufactured and prepared by Fresenius Kabi, eliminating the need for assembly or dilution at the point of care to simplify medication administration, enhance workflow efficiency, and support best practices in medication administration safety. To learn more about Fresenius Kabi’s expanding manufacturing and other operations in the U.S., visit www.MoreInAmerica.com. IMPORTANT SAFETY INFORMATION Succinylcholine Chloride Injection, USP WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS CONTRAINDICATIONS In patients with skeletal muscle myopathies In patients with known hypersensitivity to succinylcholine After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury In patients with a personal or familial history or suspected genetic susceptibility to malignant hyperthermia WARNINGS AND PRECAUTIONS Anaphylaxis: Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life-threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. Risk of Death due to Medication Errors: Unintended administration of Succinylcholine Chloride Injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. Hyperkalemia: Succinylcholine Chloride Injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. Malignant Hyperthermia: Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. Bradycardia: Intravenous bolus administration may result in profound bradycardia or, rarely asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g. atropine) may reduce the occurrence of bradyarrhythmias. ADVERSE REACTIONS Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea. 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 May Enhance the Neuromuscular Blocking Action of Succinylcholine: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. INDICATIONS AND USAGE Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: As an adjunct to general anesthesia To facilitate tracheal intubation To provide skeletal muscle relaxation during surgery or mechanical ventilation This Important Safety Information does not include all the information needed to use Succinylcholine Chloride Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Succinylcholine Chloride Injection, USP 100 mg per 5 mL and 200 mg per 10 at www.fresenius-kabi.com/us. Ephedrine Sulfate Injection, USP WARNINGS AND PRECAUTIONS Pressor Effects with Concomitant Use with Oxytocic Drugs: Pressor effect of sympathomimetic pressor amines is potentiated. Tachyphylaxis and Tolerance: Repeated administration of ephedrine may cause tachyphylaxis. ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. 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 Interactions that Augment Pressor Effect: clonidine, oxytocin and oxytocic drugs, propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor blood pressure. Interactions that Antagonize the Pressor Effect: Antagonistic effects with α-adrenergic antagonists, β-adrenergic antagonists, reserpine, quinidine, mephentermine. Monitor blood pressure. Guanethidine: Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Monitor blood pressure and adjust the dosage of pressor accordingly. Rocuronium: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed. Epidural anesthesia: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Monitor and treat the patient according to clinical practice. Theophylline: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine. INDICATIONS AND USAGE Ephedrine Sulfate Injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. This Important Safety Information does not include all the information needed to use Ephedrine Sulfate Injection, USP safely and effectively. Please see full prescribing information, for Ephedrine Sulfate Injection, USP at www.fresenius-kabi.com/us.” 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 high-quality and lifesaving 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. This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Published, peer-reviewed narrative review in CNS Spectrums compiles pharmacologic, pharmacokinetic and clinical data of VMAT2 inhibitors to highlight important differences between treatments Review presents distinctive profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concludes that VMAT2 inhibitors are not clinically interchangeable Publication provides a comprehensive resource containing clinical study results, safety profiles and use considerations to support treatment decisions SAN DIEGO, Nov. 20, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the publication of a comprehensive peer-reviewed narrative review that consolidates pharmacologic, pharmacokinetic and more than a decade of clinical research on two FDA-approved vesicular monoamine transporter 2 (VMAT2) inhibitors – INGREZZA® (valbenazine) capsules and deutetrabenazine – for the treatment of tardive dyskinesia. Among key insights, the review highlights the distinct profiles of VMAT2 inhibitors approved for tardive dyskinesia and presents unique attributes of INGREZZA: selectivity to VMAT2, a therapeutic response at the lowest available 40 mg dose and data across a wide range of patient populations. VMAT2 Inhibitors for the Treatment of Tardive Dyskinesia: A Narrative Review has been published in CNS Spectrums. "This inclusive resource will help inform healthcare providers to further understand the differences between the two available VMAT2 inhibitors for tardive dyskinesia, with the goal of supporting optimal treatment decisions for each patient," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The review findings highlight how these distinctions can carry meaningful clinical implications for drug selection, emphasizing that appropriate treatment depends on understanding each medication's unique mechanism, safety profile and dosing requirements. Notably, this includes the distinctive profile of INGREZZA with no-titration dosing and comprehensive clinical evidence." Authored by experts in psychiatry and neurology, the review highlights key differences between the two drugs. It reinforces that although both act on VMAT2, they are not interchangeable and have distinct pharmacologic, dosing and clinical profiles. Results from double-blind, placebo-controlled clinical trials, post-hoc analyses and long-term studies for each VMAT2 inhibitor are presented in the review article. Key takeaways related to INGREZZA: Pharmacology: The review notes that both approved treatments for tardive dyskinesia (TD) target inhibition of the VMAT2 receptor, while establishing the metabolism of INGREZZA to a single potent metabolite with high affinity for VMAT2 and no off-target receptor activity. Dosing and formulations: Approved VMAT2 inhibitors for TD differ in dosing and available formulations, and those considerations are highlighted throughout this review. The review also covers dosing considerations with concomitant medications and special/relevant populations (e.g., elderly, hepatic impairment). Clinical trials, post-hoc analyses and long-term studies: Results from double-blind, placebo-controlled clinical trials are presented in the review manuscript, along with post-hoc analyses that provide important context and clinical relevance for practitioners. The publication presents the extensive clinical development program of INGREZZA across diverse patient populations. As TD is a chronic condition requiring ongoing treatment, long-term study findings presented provide evidence of clinically meaningful and sustained efficacy in treating TD with INGREZZA and demonstrate a consistent tolerability profile over years of treatment across multiple studies. A supplemental reference guide accompanying the manuscript provides data on pharmacokinetics, dosing considerations, drug interactions and clinical findings to further educate on approved VMAT2 inhibitors for TD. About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About INGREZZA ® (valbenazine) Capsules and INGREZZA®SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0088 11/2025 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-publication-of-landmark-narrative-review-on-fda-approved-vmat2-inhibitors-demonstrating-unique-profile-of-ingrezza-valbenazine-capsules-302620990.html SOURCE Neurocrine Biosciences, Inc. Neurocrine Biosciences, Inc.  Media: Aimee White, 1-858-354-7865, media@neurocrine.com; Investors: Todd Tushla, 1-858-617-7143, ir@neurocrine.com