BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received New Drug Application (“NDA”) approval from the U.S. Food and Drug Administration (FDA) for its new presentation of potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use (RTU) bags.

新泽西州布里奇沃特市（商业新闻短讯）--Amneal Pharmaceuticals，Inc.（纳斯达克：AMRX）（“Amneal”或“公司”）今天宣布，其已获得美国食品和药物管理局（FDA）的新药申请（“NDA”）批准，用于在0.9%氯化钠注射液静脉注射（IV）即用（RTU）袋中新推出磷酸钾。

This sterile presentation reduces the compounding steps for clinicians typically required with administering the product..

这种无菌介绍减少了临床医生通常需要服用产品的配制步骤。。

Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated. The product is available as a single-dose infusion bag and is formulated without preservatives.

氯化钠注射液中的磷酸钾是一种磷替代产品，可作为磷的来源，用于纠正体重40公斤或以上的成人和儿科患者的低磷血症，当无法口服或肠内替代、不足或禁忌时。该产品可作为单剂量输液袋使用，配方不含防腐剂。

It is natural rubber latex-free and can be stored at room temperature..

它不含天然胶乳，可在室温下储存。。

In 2024, Amneal has already launched PEMRYDI RTU®, a ready-to-use formulation of pemetrexed, and FOCINVEZ®, a ready-to-use version of fosaprepitant. Both products offer hospitals and oncology clinics new, value-added presentations that should improve pharmacy efficiency by eliminating preparation steps.

2024年，Amneal已经推出了PEMRYDI RTU®（培美曲塞的即用制剂）和FOCINVEZ®（fosaprepitant的即用版本）。这两种产品都为医院和肿瘤诊所提供了新的增值演示，可以通过消除准备步骤来提高药房的效率。

The expected third quarter launch of potassium phosphates injection IV bag represents the Company’s third 505(b)(2) launch this year..

预计第三季度将推出磷酸钾注射液IV袋，这是该公司今年第三次推出505（b）（2）。。

“We are pleased to offer this new differentiated injectable product to hospitals,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “This new IV parenteral infusion bag is preservative-free and can be stored at room temperature. With the addition of new 505(b)(2) injectables, we are meaningfully expanding our injectables portfolio.”.

“我们很高兴为医院提供这种新的差异化注射产品，”执行副总裁兼仿制药首席商务官安迪·博耶（AndyBoyer）说。“这种新的静脉注射输液袋不含防腐剂，可以在室温下储存。随着新的505（b）（2）注射剂的加入，我们正在有意义地扩大我们的注射剂组合。”。

'Our third 505(b)(2) injectable product approval this year reflects our deep capabilities in developing new and impactful complex products. We look forward to bringing more innovative 505(b)(2) injectable products to market over the coming years,' said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Generics..

“我们今年第三次获得505（b）（2）注射剂产品批准，反映了我们在开发新的和有影响力的复杂产品方面的强大能力。高级副总裁兼仿制药首席科学官Srinivas Kone博士说，我们期待着在未来几年将更多创新的505（b）（2）注射剂产品推向市场。。

Adverse effects reported for the potassium phosphates injection IV bags include hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia. For full prescribing information, see package insert located here.

。有关完整的处方信息，请参阅此处的包装插页。

About Amneal

关于Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars.

Amneal Pharmaceuticals，Inc.（纳斯达克股票代码：AMRX），总部位于新泽西州布里奇沃特，是一家全球性制药公司。我们通过主要在美国境内开发、制造和分销280多种药品组合，使健康成为可能。在仿制药领域，该公司正在扩展广泛的复杂产品类别和治疗领域，包括注射剂和生物仿制药。

In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S.

在其专业领域，Amneal拥有越来越多的品牌药品组合，主要关注中枢神经系统和内分泌疾病，并有一条专注于未满足需求的渠道。通过其AvKARE分部，该公司是美国药品和其他产品的分销商。