Piperacillin Sodium/Tazobactam Sodium

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2400370磷酸川芎嗪注射液(供静脉注射用)山东益健药业有限公司————2025年11月10日2CYHB2401516注射用哌拉西林钠他唑巴坦钠山东安信制药有限公司————2025年11月07日3CYHB2450537多索茶碱片浙江昂利康制药股份有限公司国药准字H202582472025年11月07日4CYHB2450538多索茶碱片浙江昂利康制药股份有限公司————2025年11月07日5CYHB2500010氯化钾颗粒重庆药谷制药有限公司————2025年11月07日6CYHB2500011氯化钾颗粒重庆药谷制药有限公司————2025年11月07日7CYHB2500152甲硝唑氯化钠注射液广东科泓药业有限公司————2025年11月10日8CYHB2500180氧庆阳市千宁气体有限公司————2025年11月10日9CYHB2501229口服补液盐散（Ⅲ）成都恒瑞制药有限公司————2025年11月07日10CYHB2501332复方多黏菌素B软膏浙江孚诺医药股份有限公司————2025年11月10日11CYHB2501424舒沃替尼片迪哲（江苏）医药股份有限公司————2025年11月10日12CYHB2501425舒沃替尼片迪哲（江苏）医药股份有限公司————2025年11月10日13CYHB2501587氨酚曲马多片西安杨森制药有限公司————2025年11月07日14CYHB2501593葡萄糖氯化钠注射液成都青山利康药业股份有限公司————2025年11月10日15CYHB2501594葡萄糖氯化钠注射液成都青山利康药业股份有限公司————2025年11月10日16CYHB2501595葡萄糖氯化钠注射液成都青山利康药业股份有限公司————2025年11月10日17CYHB2501600注射用还原型谷胱甘肽瑞阳制药股份有限公司————2025年11月10日18CYHB2501652单硝酸异山梨酯缓释片西藏诺迪康科技发展有限公司————2025年11月10日19CYHB2501653单硝酸异山梨酯缓释片西藏诺迪康科技发展有限公司————2025年11月10日20CYHB2501688盐酸拉贝洛尔注射液南京斯泰尔医药科技有限公司————2025年11月10日21CYHB2501784盐酸伐昔洛韦片安士制药（中山）有限公司————2025年11月10日22CYHB2502037对乙酰氨基酚注射液广东星昊药业有限公司————2025年11月07日23CYHB2502048托吡卡胺滴眼液吉林省祈克药业有限公司————2025年11月07日24CYHB2502049托吡卡胺滴眼液吉林省祈克药业有限公司————2025年11月07日25CYHB2502050盐酸雷尼替丁胶囊吉林省祈克药业有限公司————2025年11月07日26CYHB2502082利福平片吉林省祈克药业有限公司————2025年11月07日27CYHB2502083氯霉素片吉林省祈克药业有限公司————2025年11月07日28CYHB2502102乳酶生片吉林省祈克药业有限公司————2025年11月07日29CYHB2502104吡拉西坦片吉林省祈克药业有限公司————2025年11月07日30CYHB2502109吉他霉素片吉林省祈克药业有限公司————2025年11月07日31CYHB2502110氯芬黄敏片吉林省祈克药业有限公司————2025年11月07日32CYHB2502113双氯芬酸钠肠溶片吉林省祈克药业有限公司————2025年11月07日33CYHB2502147羧甲司坦片黑龙江君安药业集团鸿祥制药有限公司————2025年11月07日34CYHB2502223他克莫司软膏武汉江承医药科技有限公司————2025年11月07日35CYHB2502224他克莫司软膏武汉江承医药科技有限公司————2025年11月07日36CYSB2400190猪纤维蛋白粘合剂上海利康瑞生物工程有限公司国药准字S202580212025年11月07日37CYSB2400266司普奇拜单抗注射液成都康诺行生物医药科技有限公司国药准字S202580222025年11月07日38CYSB2500022贝伐珠单抗注射液齐鲁制药有限公司————2025年11月07日39CYSB2500160冻干人用狂犬病疫苗（人二倍体细胞）北京民海生物科技有限公司————2025年11月07日40CYZB2502297夏枯草片雅安迅康药业有限公司————2025年11月07日41CYZB2502302脉舒平袋泡茶内蒙古五疗堂药品技术开发有限公司————2025年11月07日42CYZB2502306痰咳净片修正药业集团天汉药业有限公司————2025年11月07日43CYZB2502307感冒灵胶囊修正药业集团天汉药业有限公司————2025年11月07日44CYZB2502331乳泉颗粒天方药业有限公司————2025年11月07日45CYZB2502333产妇安颗粒天方药业有限公司————2025年11月07日46JTH2500153丁丙诺啡-N-氧化物萌蒂（中国）制药有限公司————2025年11月07日47JYHB2500020脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日48JYHB2500021脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日49JYHB2500022脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日50JYHB2500023脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日51JYHB2500024脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日52JYHB2500418注射用舒巴坦钠/注射用度洛巴坦钠组合包装再鼎医药（上海）有限公司————2025年11月10日53JYHB2500424糠酸氟替卡松鼻用喷雾剂葛兰素史克（中国）投资有限公司————2025年11月10日54JYHB2500431硝酸异山梨酯注射液珠海英联医药有限公司————2025年11月10日55JYHB2500432硝酸异山梨酯注射液珠海英联医药有限公司————2025年11月10日56JYHB2500468厄达替尼片西安杨森制药有限公司————2025年11月10日57JYHB2500469厄达替尼片西安杨森制药有限公司————2025年11月10日58JYHB2500470厄达替尼片西安杨森制药有限公司————2025年11月10日59JYHB2500472马来酸阿法替尼片勃林格殷格翰(中国)投资有限公司————2025年11月10日60JYHB2500473马来酸阿法替尼片勃林格殷格翰(中国)投资有限公司————2025年11月10日61JYHB2500483枸橼酸托法替布片辉瑞投资有限公司————2025年11月10日62JYHB2500559咪唑斯汀缓释片欧彼乐健康科技（上海）有限公司————2025年11月07日63JYHZ2500120瑞戈非尼片拜耳医药保健有限公司国药准字HJ201713002025年11月10日64JYHZ2500122阿奇霉素片梯瓦医药信息咨询（上海）有限公司国药准字HJ201602462025年11月10日65JYHZ2500123阿奇霉素片梯瓦医药信息咨询（上海）有限公司国药准字HJ201602472025年11月10日66JYHZ2500126咪康唑口腔贴片赛生医药（中国）有限公司国药准字HJ202000652025年11月10日67JYHZ2500130美阿沙坦钾片天津武田药品有限公司国药准字HJ202100032025年11月10日68JYHZ2500131美阿沙坦钾片天津武田药品有限公司国药准字HJ202100042025年11月10日69JYHZ2500132阿贝西利片礼来苏州制药有限公司国药准字HJ202000692025年11月10日70JYHZ2500133阿贝西利片礼来苏州制药有限公司国药准字HJ202000682025年11月10日71JYHZ2500134阿贝西利片礼来苏州制药有限公司国药准字HJ202000672025年11月10日72JYSB2500080注射用拉布立海赛诺菲（中国）投资有限公司————2025年11月07日73JYSB2500194乌司奴单抗注射液西安杨森制药有限公司————2025年11月07日74JYSB2500195乌司奴单抗注射液西安杨森制药有限公司————2025年11月07日75JYSB2500196乌司奴单抗注射液西安杨森制药有限公司————2025年11月07日

CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, announced approval from the U.S. Food and Drug Administration (FDA) for CONTEPO (fosfomycin) for injection for the treatment of adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. CONTEPO, an intravenous (IV) antibiotic that is an injectable epoxide and sole antibiotic class member, has demonstrated activity against gram-negative bacteria including Escherichia coli and Klebsiella pneumoniae that cause cUTIs.1,2 It has no known cross-resistance to other antibiotic classes.3,4 Targeting bacteria’s cell wall at an earlier stage than β-lactam antibiotics, CONTEPO’s unique mechanism of action inhibits the first committed step in bacterial cell wall synthesis, eliminating all downstream signaling that is vital to cell survival and leading to the destruction of the bacteria.2 “The escalating public health issue of antimicrobial resistance and emergence of highly resistant organisms demands immediate attention and innovative therapeutic solutions. The approval of CONTEPO is a major milestone in our company’s evolution and the fight against the ongoing threat of antibiotic resistance,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “We are proud to add a second branded product to our growing portfolio of anti-infectives and antibiotics and look forward to delivering this high-quality and effective antibiotic medicine to patients and providers.” The FDA approval is supported by data from the pivotal Phase 2/3 ZEUS (ZTI-01) trial which investigated the safety and efficacy of the treatment on hospitalized patients with cUTI, including acute pyelonephritis. The trial showed that intravenous (IV) fosfomycin was noninferior to piperacillin/tazobactam for the primary efficacy endpoint—overall success, defined as clinical cure and microbiologic eradication—at the test-of-cure visit in the microbiological modified intent-to-treat (mMITT) population. Overall success was achieved in 63.5% (108/170) of patients receiving IV fosfomycin and 55.6% (94/169) of those receiving piperacillin/tazobactam, with a treatment difference of 7.9 (95% CI -3.1 to 18.9). The safety and tolerability profile of CONTEPO was generally well-tolerated.2 The most commonly reported adverse reactions in ≥2% of CONTEPO patients in the study included transaminase elevations (10.3%), hypokalemia (9.9%), neutropenia (6.4%), nausea (4.3%), diarrhea (3.9%), vomiting (3.9%), hypocalcemia (3.9%), hypernatremia (3.4%), headache (2.6%), and hypophosphatemia (2.1%). "The rise of multi-drug-resistant pathogens poses a significant threat to our ability to combat infectious diseases, underscoring the continued need for novel therapies that target resistant organisms in patients having cUTIs," said Dr. Keith S. Kaye, MD, MPH Chief, Division of Allergy, Immunology and Infectious Diseases at the Robert Wood Johnson Medical School. “With an estimated three million cases of cUTIs treated in the hospital setting annually, there is a critical need for a safe and effective treatment option.5 CONTEPO’s safety, efficacy, and novel mechanism of action makes it a favorable new treatment option,” said Dr. Keith Robinson, Chief Medical Officer of Meitheal Pharmaceuticals. With this approval, Meitheal’s portfolio has rapidly expanded to over 70 on-market products with additional generic launches expected before the end of the year across its core therapeutic areas of anti-infectives, anesthetics, critical care, fertility, and oncology. ABOUT CONTEPO CONTEPO (fosfomycin) for injection is a novel, intravenous antibiotic and is the only FDA approved epoxide antibacterial product. Part of a different class of antibiotics known as phosphonics, CONTEPO covalently binds and inhibits phosphoenolpyruvate transferase (MurA) which prevents the formation of cell wall precursors, blocks cell wall synthesis and leads to the destruction of bacteria. It has demonstrated activity against gram-negative bacteria including Escherichia coli and Klebsiella pneumoniae and other antimicrobial resistant pathogens. Efficacy and safety in patients have been demonstrated in adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. INDICATIONS AND USAGE CONTEPO (fosfomycin) is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications CONTEPO is contraindicated in patients with known serious hypersensitivity to fosfomycin, or any of the excipients. Warning and Precautions Serum Electrolyte Abnormalities: CONTEPO contains 1,980 mg of sodium in each vial. The high sodium load associated with the use of CONTEPO may result in changes in serum electrolytes, such as increased levels of serum sodium and decreased levels of potassium, calcium, and phosphorous. Electrolyte disturbances, such as hypokalemia and hypocalcemia, may potentiate cardiac effects, including QT prolongation. In a phase 2/3 comparator-controlled clinical trial in patients with cUTI, the following occurred more frequently in CONTEPO-treated patients compared with piperacillin/tazobactam-treated patients: hypokalemia (9.9%), hypernatremia (3.4%), hypophosphatemia (2.1%), and hypocalcemia (3.9%). Monitor serum electrolyte levels and fluid status during treatment with CONTEPO. Electrolyte supplementation may be necessary in some cases. Monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload. QT Prolongation: CONTEPO has been shown to prolong the QT interval in some patients. QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The risk of QT prolongation may increase in patients with electrolyte abnormalities, or those that have conditions or take medications that may cause an electrolyte imbalance. Avoid CONTEPO in patients with known QT prolongation or ventricular arrhythmias, including a history of torsade de pointes. Monitor electrolytes during treatment with CONTEPO. Increase Transaminase Levels: In a phase 2/3 clinical trial, increases in transaminases occurred more frequently in CONTEPO-treated patients compared to piperacillin/tazobactam-treated patients. Transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)) were elevated > 3x upper limit of normal (ULN) in 10.3% of patients receiving CONTEPO and 4.8% of patients receiving piperacillin/tazobactam. Transaminase elevations were asymptomatic and reversible. Monitor hepatic enzymes during CONTEPO treatment. Hypersensitivity Reactions: Hypersensitivity reactions, such as rash, urticaria, and anaphylaxis have been reported. Before initiating therapy with CONTEPO, it is important to inquire about previous hypersensitivity reactions to oral or parenteral fosfomycin. If an allergic reaction to CONTEPO occurs, discontinue the drug immediately. Neutropenia Including Agranulocytosis: Neutropenia has been reported in patients receiving IV fosfomycin therapy. Monitor complete blood counts during CONTEPO therapy particularly in patients with pre-existing conditions or patients receiving concomitant drugs that may predispose to bone marrow suppression. Discontinue CONTEPO if neutropenia occurs and consider alternative therapies. Clostridioides difficile-Associated Diarrhea: Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all systemic antibacterial agents, including CONTEPO, and may range in severity from mild to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after administration of antibacterial agents. If CDAD is confirmed, discontinue antibacterials not directed against C. difficile, if possible. Development of Drug-resistant Bacteria: Prescribing CONTEPO in the absence of a proven or strongly suspected bacterial infection indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most common adverse reactions occurring in ≥ 2% of patients receiving CONTEPO were transaminase elevations (10.3%), hypokalemia (9.9%), neutropenia (6.4%), nausea (4.3%), diarrhea (3.9%), vomiting (3.9%), hypocalcemia (3.9%), hypernatremia (3.4%), headache (2.6%), and hypophosphatemia (2.1%). Drug Interactions Avoid co-administration of CONTEPO with drugs known to prolong the QT interval. Use in Specific Populations Lactation: Breastfeeding is not recommended during treatment and 24 hours after the last dose. Geriatric Use: Because elderly patients are more likely to have decreased cardiac and renal function, care should be taken in dose selection, and electrolytes, fluid status, and renal function should be monitored. Dosage adjustment in elderly patients should take into account renal function. Renal Impairment: Dosage adjustment is required for patients with estimated CLcr 50 mL/min or less. Monitor estimated CLcr at least daily and adjust the dosage of CONTEPO accordingly. In patients requiring hemodialysis, CONTEPO should be administered after hemodialysis on hemodialysis days. Hepatic Impairment: Monitor patients with severe hepatic impairment closely for fluid overload and electrolyte abnormalities. Please click here for Full Prescribing Information. ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 70 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of October 2025, Meitheal, directly or through its partners, has 40 products in the research and development phase, 6 additional products planned for launch in 2025, 4 products in clinical trial phases, and 22 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked regularly as one of Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com. REFERENCES 1. Raz R. Fosfomycin: an old--new antibiotic. Clinical Microbiology and Infection: The Official Publication of the European Society of Clinical Microbiology and Infectious Diseases. 2012;18(1):4-7. 2. Kaye KS, Rice LB, Dane AL, et al. Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America. 2019;69(12):2045-2056. 3. Falagas M, Vouloumanou E, Samonis G, et al. Fosfomycin. Clinical Microbiology Reviews 2016;29(2):321-47. 4. Prescribing Information. CONTEPO (fosfomycin) for injection, for intravenous use. Meitheal Pharmaceuticals. 2025. 5. Lodise TP, Chopra T, Nathanson BH, Sulham K, Rodriguez M. Epidemiology of Complicated Urinary Tract Infections due to Enterobacterales Among Adult Patients Presenting in Emergency Departments Across the United States. Open Forum Infect Dis. 2022;9(7):ofac315. Published 2022 Jun 24.