Viatris 提交低剂量雌激素每周贴剂的 NDA

Viatris 于 2025 年第三季度末向 FDA 提交了其低剂量雌激素每周贴剂的 NDA。该公司预计将于 2026 年年中获得批准。这标志着该资产从开发阶段进入监管审查阶段。

关键事实

申报时间: 2025年11月6日 12:53
事件: 申请已提交
方向: 中性
公司: VTRSViatris
资产: low-dose estrogen
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 exhibit991-3q25earningsrel.htm EX-99.1 Document Viatris Reports Third Quarter 2025 Results and Updates 2025 Financial Guidance • Delivers Total Revenues in Line With Expectations, Reflecting Strong Execution of its Global Business • Makes Late-Stage Pipeline Progress Including NDA Submission for Low-Dose Estrogen Weekly Patch • Acquires Aculys Pharma Including Rights to Pitolisant in Japan and Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region • Returns More Than $920 Million of Capital to Shareholders Year-to-Date, Including $500 Million in Share Repurchases • Raises and Narrows 2025 Financial Guidance Ranges for Total Revenues, Adjusted EBITDA and Adjusted EPS [1] PITTSBURGH – November 6, 2025 – Viatris Inc. (Nasdaq: VTRS) today reported strong third

SEC 8-K