BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This product is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, and is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa..

新泽西州布里奇沃特（商业新闻短讯）--Amneal Pharmaceuticals，Inc.（纳斯达克：AMRX）（“Amneal”或“公司”）今天宣布，已获得美国食品和药物管理局（“FDA”）对环丙沙星和地塞米松耳用混悬剂的缩写新药申请（“ANDA”）批准。本产品是环丙沙星（一种氟喹诺酮类抗菌药物）和地塞米松（一种皮质类固醇）的组合，适用于治疗由儿科（6个月及以上），成人和老年患者急性外耳炎（AOE）中指定微生物的易感分离株引起的感染。金黄色葡萄球菌和铜绿假单胞菌。。

“This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”.

执行副总裁兼仿制药首席商务官安迪·博耶（AndyBoyer）表示：“这项批准意味着又增加了一种复杂、高价值的药物。”。“这反映了我们领先的负担得起的药物组合正在向复杂产品转变，以及我们业务的持续成功多样化。”。

The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%). For full prescribing information, see package insert located here.

环丙沙星和地塞米松耳用混悬液报告的最常见不良反应是耳痛（2.3%），耳朵不适（3%）和耳朵瘙痒（1.5%）。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 270 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270多种医药产品，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。

federal government, retail, and institutional markets. For more information, please visit www.amneal.com..

联邦政府、零售和机构市场。有关更多信息，请访问www.amneal.com。。

Cautionary Statement on Forward-Looking Statements

关于前瞻性声明的警示声明

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements.

本文中包含的关于非历史事实的某些陈述可能是前瞻性陈述（定义见1995年《美国私人证券诉讼改革法案》）。此类前瞻性陈述包括有关管理层意图、计划、信念、期望、财务结果或未来预测的陈述，其中包括：对未来运营的讨论；预期或估计的经营成果和财务业绩；以及关于我们定位的声明，包括我们推动可持续长期增长的能力，以及其他非历史性声明。

Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements..

诸如“计划”、“预期”、“将”、“预期”、“估计”等词语以及类似词语或其否定词旨在识别估计和前瞻性陈述。。

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events.

提醒读者不要依赖这些前瞻性陈述。这些前瞻性陈述基于对未来事件的当前预期，包括未来市场状况、公司业绩和财务业绩、运营投资、业务前景、新战略和增长举措、竞争环境和其他事件。

If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company..

如果基础假设不准确或已知或未知的风险或不确定性出现，实际结果可能与公司的预期和预测有很大差异。。

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S.

此类风险和不确定性包括但不限于：我们及时成功开发、许可、获取和商业化新产品的能力；我们在制药行业面临来自品牌和仿制药公司的竞争，以及这种竞争对我们定价能力的影响；我们获得产品独家营销权的能力；我们的收入来自有限数量产品的销售，其中很大一部分是通过有限数量的客户获得的；供应链中长期业务中断的影响；某些客户群的持续整合趋势；我们对第三方供应商和分销商的产品原材料和某些制成品的依赖；我们的品牌竞争对手在法律、监管和立法方面的努力，以阻止我们的通用替代品的竞争；我们对信息技术系统和基础设施的依赖以及网络安全事件的可能性；我们吸引、雇佣和留住高技能人才的能力；与联邦法规有关的品牌和仿制药制造商之间安排的风险；我们不时依赖专有技术的某些许可证；我们在研究和开发上花费的大量资源；第三方对我们提出索赔的风险；与监管环境变化相关的风险，包括美国。

federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authoritie.

与医疗欺诈滥用和健康信息隐私和安全相关的联邦和州法律以及此类法律的变更；食品和药物管理局产品批准要求的变更；医疗改革的影响以及政府当局在覆盖率和报销水平方面的变化。