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Elanco Animal Health Shares Sink On Unexpected Label Update For Canine Dermatology Drug

Elanco Animal Health Shares Sink On Unexpected Label Update For Canine Dermatology Drug

elanco animal health股價因其犬皮膚病藥物意外的標籤更新而下跌。
Benzinga ·  06/28 00:25
Elanco Animal Health Incorporated (NYSE:ELAN) stock is tumbling as the company released updates to the expected FDA approval timelines for Zenrelia and Credelio Quattro.
隨着公司發佈Zenrelia和Credelio Quattro預期FDA批准時間的更新,Elanco Animal Health Incorporated (NYSE:ELAN)股價正在下跌。
Zenrelia is a JAK Inhibitor that controls pruritus and atopic dermatitis in dogs.
Zenrelia是一種JAK抑制劑,可控制犬的瘙癢和特應性皮炎。
For Zenrelia, the FDA confirmed that all major technical sections (Effectiveness, Safety and Chemistry, Manufacturing, and Controls (CMC)) are complete as of late June.
對於Zenrelia,FDA確認自6月末以來,所有主要技術部分(有效性,安全性和化學,製造和控制(CMC))均已完成。
For the minor technical section for labeling, earlier this week, the company aligned with the FDA on the language and expects to receive the completion letter by mid-July.
對於較小的技術部分:標籤,本週早些時候,公司與FDA就語言達成一致,並預計將在7月中旬收到完成信函。
The 60-day final administrative review will follow, placing expected...
60天的最終行政審...

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