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Avenacy宣布在美国市场推出氨甲环酸注射液,USP

Avenacy Announces Launch of Tranexamic Acid Injection, USP in the U.S. Market

businesswire 等信源发布 2024-06-24 17:59

可切换为仅中文


SCHAUMBURG, Ill.--(BUSINESS WIRE)--Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Tranexamic Acid Injection, USP in the United States as a therapeutic generic equivalent for Cyklokapron® as approved by the U.S. Food and Drug Administration.

伊利诺伊州绍姆堡(商业新闻短讯)--专注于提供关键注射药物的专业制药公司Avenacy今天宣布,经美国食品和药物管理局批准,已在美国推出美国药典氨甲环酸注射液,作为CYKLOKPAPORT®的治疗通用等效物。

Tranexamic Acid Injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction..

氨甲环酸注射液,USP适用于血友病患者短期使用(2至8天),以减少或预防出血,并减少拔牙期间和拔牙后替代治疗的需要。。

“In less than one year since starting Avenacy, we have launched ten essential injectable medications – a formidable achievement and testament to our commercial expertise in specialty pharmaceuticals,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “Since our company’s inception in October 2023, we have aimed to quickly deliver safe, effective, quality specialty injectables to hospitals and providers across the U.S., and the launch of Tranexamic Acid injection marks another important step in fulfilling this mission.

Avenacy联合创始人兼首席执行官杰夫·约登(Jeff Yordon)表示:“在创立Avenacy不到一年的时间里,我们推出了十种基本的注射药物,这是一项了不起的成就,也是我们在专业药物领域商业专长的证明。”。“自我们公司于2023年10月成立以来,我们一直致力于向美国各地的医院和供应商快速提供安全,有效,优质的专业注射剂,氨甲环酸注射剂的推出标志着实现这一使命的另一个重要步骤。

The rest of 2024 is poised to be a transformative year for the business, as we remain focused on launching several additional products.”.

2024年剩下的时间将是业务变革的一年,因为我们仍然专注于推出一些其他产品。”。

Avenacy's Tranexamic Acid Injection, USP is available in 1,000 mg/10 mL (100 mg per mL) 10-pack single-dose vials. In line with Avenacy’s mission to champion patient safety and streamline patient care, Tranexamic Acid Injection, USP will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection..

Avenacy的氨甲环酸注射液USP有1000毫克/10毫升(100毫克/毫升)10包单剂量小瓶。根据Avenacy维护患者安全和简化患者护理的使命,氨甲环酸注射液,USP将采用该公司高度分化的包装和标签,以支持准确的药物选择。。

Avenacy will begin shipping Tranexamic Acid Injection, USP to wholesale partners this week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards.

Avenacy将于本周开始向批发合作伙伴运送美国药典氨甲环酸注射液。该公司得到了全球开发和合同制造合作伙伴网络的支持,这些合作伙伴已经根据cGMP标准成功接受了FDA的检查。

Tranexamic Acid Injection, USP had U.S. sales of approximately $28 million for the twelve months ending in June 2023.1

美国药典氨甲环酸注射液在截至2023年6月的12个月内在美国的销售额约为2800万美元

Please see link for Full Prescribing Information.

有关完整的处方信息,请参阅链接。

Cyklokapron® is a registered trademark of Pfizer.

环己酮® 是辉瑞公司的注册商标。

1Source: IQVIA

1来源:IQVIA

About Avenacy

关于Avenacy

Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain.

Avenacy是一家总部位于美国的专业制药公司,专注于提供关键的注射药物,用于在各种医疗监督环境中治疗患者,从急诊医院到门诊诊所和医生办公室。通过严格和优化的选择过程,该公司正在建立一条高质量的FDA批准的注射产品管道,以确保有弹性的组合能够满足当今动态药物供应链的需求。

With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications..

凭借经验丰富的团队、对质量和可靠性的承诺以及旨在促进安全高效的患者护理的产品,Avenacy努力成为基本药物领域值得信赖的合作伙伴。。

Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit http://www.avenacy.com/.

Avenacy成立于2023年,总部位于伊利诺伊州绍姆堡。有关更多信息,请访问http://www.avenacy.com/.