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The U.S. Food and Drug Administration (FDA) has granted approval for Cardamyst, a nasal spray designed to address heart rhythm issues, following a lengthy regulatory process. The approval comes after two previous setbacks for the product, including a refusal-to-file letter issued in late 2023 and additional concerns raised in March 2025 regarding manufacturing practices..

美国食品和药物管理局（FDA）在经历了一段漫长的监管过程后，批准了用于解决心律问题的鼻喷剂Cardamyst。该产品此前曾遭遇两次挫折，包括2023年底发出的拒绝受理函，以及2025年3月对生产规范提出的额外担忧。

The initial refusal-to-file letter from the FDA indicated that the application did not meet necessary requirements for review. Subsequently, earlier this year, regulators identified specific manufacturing issues that needed resolution before further consideration could proceed. After addressing these concerns, the company successfully navigated the regulatory hurdles, culminating in the FDA’s decision to approve Cardamyst.

美国食品药品监督管理局（FDA）最初的拒绝受理函表明，该申请未达到审查的必要要求。随后，今年早些时候，监管机构指出了需要解决的具体生产问题，然后才能进一步审议。在解决这些问题后，该公司成功克服了监管障碍，最终促使FDA批准了Cardamyst。

This marks the end of an extended approval process for the treatment aimed at managing heart rhythm conditions..

这标志着针对管理心律状况的治疗的漫长审批过程的结束。

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Date: December 15, 2025

日期：2025年12月15日

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