瑞特多斯制药公司获得FDA批准，生产0.5%（2.5毫克/0.5毫升）硫酸沙丁胺醇吸入溶液—

Ritedose Pharmaceuticals Receives FDA Approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*--Addressing Nationwide Shortage of the Essential Drug

CISION 等信源发布 2025-05-20 20:32

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Ritedose has the largest

莱特剂量拥有最大的

portfolio of nebulizer products, with new dosage completing the company's portfolio of albuterol treatments

雾化器产品组合，新剂量完善了公司的沙丁胺醇治疗产品组合

COLUMBIA, S.C.

哥伦比亚，南卡罗来纳州

，

May 20, 2025

2025年5月20日

/PRNewswire/ -- Ritedose Pharmaceuticals, a division of

/PRNewswire/ -- Ritedose Pharmaceuticals，一个部门属于

The Ritedose Corporation (Ritedose)

瑞特多斯公司 (Ritedose)

, the largest sterile contract development manufacturing organization (CDMO) in the US specializing in aseptic unit-dose medication production using Blow-Fill-Seal (BFS) technology, received US Food and Drug Administration (FDA)

，美国最大的无菌合同开发制造组织（CDMO），专注于使用吹灌封（BFS）技术生产无菌单剂量药物，获得了美国食品药品监督管理局（FDA）的批准。

approval

批准

for manufacturing and distributing generic Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*

用于制造和分销通用型硫酸沙丁胺醇吸入溶液，0.5%（2.5毫克/0.5毫升）*

'Driven by the needs of escalating health demands in the U.S., Ritedose is strategically expanding its support for critical respiratory therapies. For the more than 26 million patients suffering from bronchospasms associated with reversible obstructive airway diseases like asthma, this approval brings much-needed access to a critical therapy,' said .

“由于美国不断增长的健康需求，Ritedose正在战略性地扩大对关键呼吸治疗的支持。对于超过2600万患有与可逆性阻塞性气道疾病（如哮喘）相关的支气管痉挛患者来说，此次批准为他们带来了亟需的关键治疗途径，”该公司表示。

Jody Chastain

乔迪·查斯坦

, CEO of Ritedose. 'Amid a national shortage of this essential drug, we're proud to step-up and help bridge the gap with a full range of albuterol dosages. Patients are at the center of everything we do here at Ritedose.'

Ritedose首席执行官表示：“在全国范围内这种基本药物短缺的情况下，我们很自豪能够挺身而出，提供全系列的沙丁胺醇剂量来帮助填补这一空白。在Ritedose，患者是我们一切工作的核心。”

To date, Ritedose has the largest portfolio of nebulizer products available—having delivered more than 4.5 billion doses over the company's lifetime. The albuterol doses will be manufactured in the company's expanded, state-of-the-art facilities using its advanced BFS technology, which ensures an automated, safe and reliable process.

迄今为止，Ritedose拥有市场上最丰富的雾化器产品组合，在公司的发展历程中已交付超过45亿剂药物。沙丁胺醇制剂将利用公司先进的BFS技术，在其扩建的、最先进的设施中生产，该技术确保了自动化、安全且可靠的生产流程。

Each single dose will be preservative-free, as well as individually wrapped and barcoded..

每支单剂量将不含防腐剂，并且单独包装和条形码。

The 2.5 mg/0.5 ml dosage rounds out Ritedose's complete portfolio of albuterol treatments, as the company currently has approved applications for (2.5 mg/3 mL (0.083%), 1.25 mg/3 mL and 0.63 mg/3 mL) strength products as well. This new dosage also helps address a nationwide shortage of the essential drug, which has been reported by the FDA since .

2.5毫克/0.5毫升的剂量完善了Ritedose公司完整的沙丁胺醇治疗产品组合，因为该公司目前已拥有（2.5毫克/3毫升（0.083%）、1.25毫克/3毫升和0.63毫克/3毫升）强度产品的批准申请。这一新剂量也有助于缓解这种自FDA报告以来在全国范围内短缺的关键药物的供应问题。

October 2022

2022年10月

. Ritedose estimates that the dosage will be available starting in the second quarter of 2025.

Ritedose 估计该剂量将从 2025 年第二季度开始供应。

Chastain continued, 'Our recent expansion and new packaging line ensures we have the capacity to deliver this medication consistently, efficiently, and safely. This milestone reflects the dedication of our hard-working employees, whose commitment is to meet a real and urgent need for patients both in their communities and in communities across the country.'.

查斯坦继续说道：“我们最近的扩张和新包装线确保我们有能力持续、高效且安全地交付这种药物。这一里程碑反映了我们辛勤工作的员工的奉献精神，他们的承诺是为了满足患者在其社区及全国各地社区中的真实且迫切的需求。”

The drug is

这种药物是

primarily used

主要使用

to provide relief of bronchospasms in patients older than 12 years with reversible obstructive airway disease (asthma), and for treating acute attacks of bronchospasm. In

用于缓解12岁以上可逆性阻塞性气道疾病（哮喘）患者的支气管痉挛，并用于治疗急性支气管痉挛发作。

the United States

美国

alone, more than 26 million people are known to have asthma, and about 7 million of them are children.

仅在美国，已知有超过2600万人患有哮喘，其中约700万是儿童。

This announcement comes on the heels of Ritedose

这一宣布紧随Ritedose而来。

recently announcing

最近宣布

the addition of its seventh Syntegon packaging line to expand single vial packaging capabilities.

添加第七条Syntegon包装线以扩展单个小瓶包装能力。

*Potency expressed as albuterol, equivalent to 3 mg of albuterol sulfate

*效力以沙丁胺醇表示，相当于3毫克硫酸沙丁胺醇

About The Ritedose Corporation

关于The Ritedose公司

Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The company's process guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications.

Ritedose是美国最大的无菌合同开发制造组织（CDMO），专注于无菌吹灌封（BFS）技术，确保无菌、一致且安全的单位剂量递送。该公司工艺指导从临床试验到品牌和仿制吸入及眼科药物商业化的分子开发。

With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. Ritedose: Passion and Precision with a Purpose. For more information visit .

专注于质量、创新和客户满意度，Ritedose与领先的制药公司合作，提供安全、有效且可靠的药物，改善患者治疗效果。Ritedose：满怀热情与精准，心怀使命。欲了解更多信息，请访问。

Ritedose.com

里特剂量网

Media Contact:

媒体联系人:

Alex Keown

亚历克斯·基翁

Inspire Agency on Behalf of Ritedose

代表Ritedose的Inspire机构

630.346.5141

akeown@inspire-agency.com

SOURCE Ritedose