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SHIRLEY, N.Y., Oct. 19, 2023 /PRNewswire/ -- American Regent announces the launch and availability of Potassium Phosphates Injection, USP, which is FDA-approved and therapeutically equivalent to Potassium Phosphates .1 Potassium Phosphates Injection, USP is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated Continue Reading Potassium Phosphates Injection, USP is available in three presentations "An important part of our company's mission is to assist in mitigating shortages and ensuring supply of critical medications whenever possible. To that end, we are pleased to add Potassium Phosphates Injection, USP to our robust line of products that are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. This product is available for immediate shipment. Customers can order Potassium Phosphates Injection, USP, through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706. Potassium Phosphates Injection, USP is supplied as follows: See the following Important Safety Information, in addition to the product's Full Prescribing Information. For additional information, please visit . Potassium Phosphates Injection, USP For intravenous use INDICATIONS AND USAGE Potassium Phosphates Injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Potassium Phosphates Injection is contraindicated in patients with: hyperkalemia; hyperphosphatemia; hypercalcemia or significant hypocalcemia; severe renal impairment (eGFR less than 30 mL/min/1.73m2) or end stage renal disease. WARNINGS AND PRECAUTIONS Serious Cardiac Adverse Reactions with Undiluted, Bolus, or Rapid Intravenous Administration : Intravenous administration of potassium phosphates to correct hypophosphatemia in single doses of phosphorus 50 mmol and greater and/or at rapid infusion rates (over 1 to 3 hours) in intravenous fluids has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, and seizures. In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death. Administer only after dilution or admixing; do not exceed the recommended infusion rate. Continuous electrocardiographic (ECG) monitoring may be needed during infusion. Pulmonary Embolism due to Pulmonary Vascular Precipitates : Pulmonary vascular emboli and pulmonary distress related to precipitates in the pulmonary vasculature have been described in patients receiving admixed products containing calcium and phosphate or parenteral nutrition. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. Hyperkalemia : Potassium Phosphates Injection may increase the risk of hyperkalemia, including life-threatening cardiac events, especially when administered in excessive doses, undiluted or by rapid intravenous infusion. Increased risk in patients with renal impairment, severe adrenal insufficiency, or treated with drugs that increase potassium. Patients with cardiac disease may be more susceptible. Do not exceed the maximum daily amount of potassium or the recommended infusion rate. Continuous ECG monitoring may be needed during infusion. Hyperphosphatemia and Hypocalcemia: Hyperphosphatemia can occur with intravenous administration of potassium phosphates, especially in patients with renal impairment. Hyperphosphatemia can cause the formation of insoluble calcium phosphorus products with consequent hypocalcemia, neurological irritability with tetany, nephrocalcinosis with acute kidney injury and more rarely, cardiac irritability with arrhythmias. Monitor serum phosphorus and calcium concentrations during and following infusion. Aluminum Toxicity : Potassium Phosphates Injection contains aluminum that may be toxic. Patients with renal impairment, including preterm infants, can accumulate aluminum at levels associated with central nervous system and bone toxicity. Hypomagnesemia : Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment. Vein Damage and Thrombosis : Potassium Phosphates Injection must be diluted and administered in intravenous fluids or used as an admixture in parenteral nutrition. It is not for direct intravenous infusion. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. Laboratory Monitoring Monitor serum phosphorus, potassium, calcium and magnesium concentrations during treatment. ADVERSE REACTIONS Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia. The following clinically significant adverse reactions are described elsewhere in the labeling: Aluminum Toxicity; Hypomagnesemia; Vein Damage and Thrombosis DRUG INTERACTIONS Other Products that Increase Serum Potassium - Administration of Potassium Phosphates Injection to patients treated concurrently or recently with products that increase serum potassium increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia. Avoid use of Potassium Phosphates Injection in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations. USES IN SPECIFIC POPULATIONS Lactation - Phosphorus and potassium are present in human milk. Administration of the recommended dose of Potassium Phosphates Injection is not expected to cause harm to a breastfed infant. There is no information on the effects of potassium phosphates on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Potassium Phosphates Injection and any potential adverse effects on the breastfed child or from the underlying maternal condition. Pediatric Use - Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Potassium Phosphates Injection may be at higher risk of aluminum toxicity. Geriatric Use - Dose selection of Potassium Phosphates Injection for an elderly patient should be cautious, starting at the low end of the dosing range. It may be useful to monitor renal function during treatment. Renal Impairment - Potassium and phosphorus are known to be substantially excreted by the kidney and the risk of adverse reactions to Potassium Phosphates Injection may be greater in patients with impaired renal function. Use is contraindicated due to the risk of hyperkalemia in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or end stage renal disease. In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations. OVERDOSAGE Hyperphosphatemia - Administration of excessive doses of intravenous potassium phosphates in intravenous fluids and/or at rapid infusion rates has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, seizures, and tetany. Hyperkalemia - Excessive administration of phosphates given as potassium salts may also cause hyperkalemia. Manifestations of hyperkalemia include: disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation; hypotension; muscle weakness including paresthesia, muscular and respiratory paralysis. Management - In the event of overdosage, discontinue infusions containing potassium phosphates immediately and institute general supportive measures, including ECG monitoring, laboratory monitoring, and correction of serum electrolyte concentrations, especially potassium, phosphorus, calcium, and magnesium. For additional safety information, please see Full Prescribing Information. You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting or calling 1-800-FDA-1088. REF-2383 2/2022 You are encouraged to report adverse drug events (ADEs) to American Regent: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical Information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit . About Daiichi Sankyo Group Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit: . All trademarks are the property of their respective owners. Reference: 1. Orange book: Approved drug products with therapeutic equivalence evaluations. US Food & Drug Administration. Accessed September 19, 2023. PP-PO-US-0008 SOURCE American Regent, Inc.

DUBLIN, June 15, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping dexlansoprazole 30 mg capsules, a generic version of Takeda's Dexilant®. This additional dosage strength rounds out the product family, now with both 30 mg and 60 mg delayed-release capsules. "We're proud to provide this high-quality, affordable generic medication to appropriate patients," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "The dexlansoprazole product family strengthens our portfolio and our reputation as a reliable supplier." Dexlansoprazole is a proton pump inhibitor with a novel delivery system approved for the treatment of erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). According to IQVIA™, Dexilant® 30 mg sales were approximately $45 million for the 12 months ended April 30, 2023. Dexilant® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria. PPIs, including dexlansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products. WARNINGS AND PRECAUTIONS Dexlansoprazole Delayed-Release Capsules, 60 mg, contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Presence of Gastric Malignancy: In adults, symptomatic response to therapy with dexlansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy. Acute Tubulointerstitial Nephritis (TIN): TIN has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms, from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia). Discontinue dexlansoprazole and evaluate patients with suspected acute TIN. Clostridium difficile-Associated Diarrhea: Published observational studies suggest that PPI therapy like dexlansoprazole may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated. Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs. Discontinue dexlansoprazole delayed-release capsules at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Cutaneous and Systemic Lupus Erythematosus (CLE and SLE): CLE and SLE have been reported in patients taking PPIs. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. SLE is less commonly reported than CLE in patients receiving PPIs. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving dexlansoprazole delayed-release capsules, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Cyanocobalamin (Vitamin B12) Deficiency: Daily treatment with any acid-suppressing medications over a long period of time (eg, longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. Hypomagnesemia and Mineral Metabolism: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (eg, diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically. Interactions with Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. Interaction with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients. Fundic Gland Polyps: PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated. Risk of Heart Valve Thickening in Pediatric Patients Less Than Two Years of Age: Dexlansoprazole is not recommended in pediatric patients less than two years of age. ADVERSE REACTIONS Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. Patients 12 to 17 years of age (≥5%): headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause adverse effects on fetal bone growth and development. Pediatrics: Based on data with lansoprazole, dexlansoprazole is not effective in patients with symptomatic GERD 1 month to less than 1 year of age and nonclinical studies have demonstrated adverse effects in juvenile rats. INDICATIONS AND USAGE Healing of Erosive Esophagitis (EE): Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of EE for up to eight weeks. Maintenance of Healed Erosive Esophagitis and Relief of Heartburn: Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks. Please click for Full Prescribing Information. 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 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. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company'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 the Company'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. SOURCE Endo International plc

SAN DIEGO, June 16, 2022 (GLOBE NEWSWIRE) -- Lenire Biosciences Inc., a biopharmaceutical company developing novel treatments for Fragile X Syndrome (FXS) and related disorders, today announced that it has agreed to a license from UCL (University College London) for VSN16R, a small molecule positive modulator of large-conductance, calcium-activated potassium (“BK”) channels, as a novel therapy for FXS. The development of this technology was supported by UCL Business (UCLB), the commercialization company of UCL. FXS is a rare, inherited condition that can cause issues including developmental delays, learning and behavioural difficulties, physical abnormalities, anxiety, attention or hyperactivity disorders and autism spectrum disorder. FXS has been detected in all populations and ethnic groups and recent estimates suggest a prevalence of approximately 1 in 4,000 males and 1 in 8,000 females have FXS.1 VSN16R is an orally bioavailable compound based on anandamide, a natural signalling molecule in the endocannabinoid system in humans. It was developed in the laboratory of Professor David Selwood (Wolfson Institute for Biomedical Research, UCL), as part of a study that has completed phase II human trials for muscle stiffness and involuntary muscle spasms in multiple sclerosis, a common symptom known as spasticity. A large and diverse set of preclinical studies have implicated deficient BK channel activity in the etiology of FXS, and recent studies in a mouse model of the syndrome demonstrated efficacy of VSN16R in rescuing FXS-related phenotypes. Lenire plans to develop VSN16R to treat patients with FXS. “Extensive research into the role of altered BK channel expression, activity and regulation in FXS models provides a strong rationale for pharmacologically augmenting its activity as a disease-modifying treatment for FXS that may improve many of its core symptoms,” shared Dr. Peter Vanderklish, co-founder of Lenire. FXS is the most prevalent inherited form of intellectual disability and a leading cause of autism spectrum disorder. There are currently no disease-modifying therapies for FXS, and some of the most problematic symptoms, such as anxiety, are largely refractory to medications that would be used to treat them in the neurotypical population. Dr. Craig Erickson, Professor of Psychiatry at Cincinnati Children’s Hospital Medical Center and Director of the Cincinnati Fragile X Research and Treatment Center commented, “We are excited to collaborate with Lenire to test VSN16R in patients with FXS.” Professor David Selwood commented, "The effect of our drug in the disease models is transformative; we are very excited to see this drug go forward to the clinic in people with Fragile X." About Lenire Biosciences Lenire Biosciences is privately held, clinical stage biopharmaceutical company that is developing novel, patent protected therapeutics for the treatment of Fragile X Syndrome (FXS), a leading cause of intellectual disability world-wide that also presents with anxiety, attention deficit, hyperactivity, autism spectrum behaviors and other disabling symptoms. More information on the Company can be viewed at https://lenirebiosciences.com. Contact: David H. CreanChief Executive Officerdavid@lenirebiosciences.com858-461-9490 _________________________1 FRAXA Research Foundation (https://www.fraxa.org)