share_log

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

Benzinga ·  Jun 28 00:25

ElancoAnimal Health Incorporated(NYSE:ELAN) stock is tumbling as the company released updates to the expected FDA approval timelines for Zenrelia and Credelio Quattro.

Zenrelia is a JAK Inhibitor that controls pruritus and atopic dermatitis in dogs.

For Zenrelia, the FDA confirmed that all major technical sections (Effectiveness, Safety and Chemistry, Manufacturing, and Controls (CMC)) are complete as of late June.

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.

The 60-day final administrative review will follow, placing expected...

The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.
    Write a comment