Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 -
-处方药用户费法案(PDUFA)目标行动日期为2025年2月28日-
- Product has patent protection through 2043 -
-该产品通过2043年的专利保护-
DEER PARK, Ill., July 15, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or the "Company") (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company's New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025.
伊顿制药公司(“伊顿”或“公司”)(纳斯达克:ETON),一家专注于开发和商业化罕见疾病治疗的创新型制药公司,今天宣布其盐酸氢化可的松口服溶液(Et-400)的新药申请(NDA)已被美国食品药品监督管理局(FDA)接受,并已指定处方药用户费法案(PDUFA)的目标行动日期为2025年2月28日。
"The acceptance of our NDA is a significant milestone toward our efforts of bringing this important and highly in-demand liquid formulation to children. Once approved, we believe ET-400 will allow us to capture a greater percentage of the oral hydrocortisone market and, together with ALKINDI SPRINKLE, achieve combined peak sales of more than $50 million annually. We look forward to working with the FDA and preparing for a potential launch in early 2025," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
“我们的药品新药申请被接受是朝着让孩子们使用这种重要且高度需求的口服溶液迈出的重要一步。一旦批准,我们相信Et-400将使我们能够占据更大的口服氢化可的松市场份额,并且与ALKINDI SPRINKLE一起,每年实现超过5000万美元的销售最高峰。我们期待着与FDA进行合作,并为可能在2025年初推出做好准备,”Eton制药公司首席执行官Sean Brynjelsen说。
ET-400 is a proprietary room temperature stable formulation of oral hydrocortisone solution. The Company has been issued a patent related to the product by the U.S. Patent and Trademark Office that expires in 2043 and has additional patent applications currently under review.
Et-400是一种专有的常温稳定的口服氢化可的松溶液配方。该公司已获得了与该产品相关的美国专利和商标局颁发的专利,有效期至2043年,并有其他专利申请正在审核中。
About Eton Pharmaceuticals
关于伊唐制药
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO hydrocortisone autoinjector. For more information, please visit our website at .
伊顿是一家专注于研发和商业化罕见病治疗的创新性制药公司。该公司目前拥有五种罕见病产品:ALKINDI SPRINKLE,PKU GOLIKE,Carglumic Acid,Betaine Anhydrous和Nitisinone。公司目前处于三个尾期开发的产品,包括ET-400,ET-600和ZENEO水杨酸巴利昂自动注射器。欲了解更多信息,请访问我公司网站。
Forward-Looking Statements
前瞻性声明
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates, the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
本新闻稿中包含的与非历史事实有关的声明属于“前瞻性声明”,根据《1995年私人证券诉讼改革法案》,包括与伊唐制药有能力开展某些活动和达成某些目标和目的有关的声明。这些声明包括但不限于有关伊唐业务战略的声明,伊唐计划开发和商业化其产品候选品的声明,伊唐产品候选品的安全性和有效性,伊唐就监管申报和认证提出计划和预计时间,以及伊唐产品候选市场的规模和增长潜力的声明。由于这些声明面临风险和不确定性,实际结果可能与这些前瞻性声明不同。旨在识别前瞻性声明的词语包括但不限于“认为”、“预计”、“计划”、“期望”、“意图”、“将”、“目标”、“潜力”等类似字眼。这些前瞻性声明基于伊唐目前的期望和假设,这些期望和假设可能永远不会实现或被证明是不正确的。实际结果和事件时间可能因为风险和不确定性的各种原因与这些前瞻性声明所预期的不同,包括但不限于与寻找、开发和商业化作为人类治疗药物使用的安全和有效药物,以及在建立这种药物周围的业务的努力方面相关的场面及风险。关于Eton的发展计划和财务状况的这些风险和其他风险在Eton向证券交易委员会提交的文件中有更详细的描述。本新闻稿中包含的所有前瞻性声明仅于其作出的日期发表。伊唐不承担更新这些声明以反映发生或存在于其作出该等声明后的事件或情况的义务。
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
投资者关系:
英未泰客,内部沟通公司
T: 212-452-2793
E: lwilson@insitecony.com
Source: Eton Pharmaceuticals.
来源:伊顿制药公司。
Source: Eton Pharmaceuticals
来源:Eton药物