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.

伊利诺伊州鹿园，2024年7月15日（环球通讯社）--伊顿制药公司（“伊顿”或“公司”）（纳斯达克：伊顿），一家专注于开发和商业化罕见疾病治疗的创新制药公司，今天宣布该公司针对ET-400的新药申请（NDA），这是一种氢化可的松口服溶液的专利制剂，已被美国接受。

Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025..

美国食品和药物管理局（FDA），并已被指定处方药用户费用法案（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.

“接受我们的保密协议是我们努力将这种重要且需求量很大的液体制剂带给儿童的一个重要里程碑。一旦获得批准，我们相信ET-400将使我们能够在口服氢化可的松市场上占据更大的份额，并与ALKINDI Sprink®一起实现每年超过5000万美元的销售峰值。

We look forward to working with the FDA and preparing for a potential launch in early 2025,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals..

我们期待着与FDA合作，并为2025年初的潜在上市做好准备，”伊顿制药首席执行官肖恩·布林杰尔森（SeanBrynjelsen）表示。。

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是口服氢化可的松溶液的专有室温稳定制剂。该公司已获得美国专利商标局颁发的与该产品相关的专利，该专利将于2043年到期，目前正在审查其他专利申请。

About Eton Pharmaceuticals

关于伊顿制药

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.

伊顿是一家创新的制药公司，专注于开发罕见疾病的治疗方法并将其商业化。该公司目前有五种商业罕见病产品：ALKINDI Spread®，PKU GOLIKE®，Carglumic Acid，甜菜碱无水和尼替尼酮。该公司在后期开发中还有三种候选产品：ET-400、ET-600和ZENEO®氢化可的松自动注射器。