Elanco Animal Health Incorporated announced updates to the expected U.S. Food and Drug Administration (FDA) approval timelines for Zenrelia and Credelio Quattro. For Zenrelia, the company has received confirmation from FDA that all major technical sections (Effectiveness, Safety and Chemistry, Manufacturing, and Controls (CMC)) are complete as of late June. For the Labeling minor technical section, earlier this week the Company aligned with FDA on the language and expects to receive the completion letter by mid-July.

The 60-day final administrative review will follow, placing expected approval late in the third quarter of 2024. The company now anticipates a U.S. launch for Zenrelia in the fourth quarter of 2024. Zenrelia has also received its first approval in Brazil by the Brazilian Minister of Agriculture, Livestock and Food Supply, with launch planned for the fourth quarter of 2024.

Additional reviews are ongoing in other markets, including Canada, Europe and Japan. For Credelio Quattro, two of three major technical sections ? Effectiveness and Safety ?

are complete, however, in June, the Company received an incomplete letter for the CMC major technical section. Elanco has already submitted its response to the two questions in the letter, which did not require any additional data generation. The FDA has offered a shortened, 60-day review timeline for Elanco's response.

Following this, the minor technical section reviews will be completed, including Labeling. The product is then expected to go through the 60-day final administrative review, placing the expected approval in the fourth quarter of 2024, with U.S. launch expected in the first quarter of 2025. The Company continues to expect positive differentiation related to effectiveness.