Elanco Animal Health USA

CLOSEOUT LETTER Elanco Animal Health USA MARCS-CMS 710613 — August 05, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: NADA 141-550, Pradalex™ pradofloxacin injection Product: Animal & Veterinary Recipient: Recipient Name Jeffrey Simmons Recipient Title President and CEO Elanco Animal Health USA 2500 Innovation Way Greenfield , IN 46140 United States Issuing Office: Center for Veterinary Medicine United States Secondary Issuing Offices United States Dear: Mr. Simmons The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated, January 8, 2026. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter. Future FDA surveillance will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the U.S. Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent surveillance or through other means. If you have any questions or comments, please contact Dr. Christopher Loss at christopher.loss@fda.hhs.gov. If you wish to send a response, please send by email to CVMSurveillance@fda.hhs.gov. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter #710613. Sincerely, /S/ Linda Walter-Grimm, DVM Director, Division of Pharmacovigilance and Surveillance Office Surveillance and Compliance Center for Veterinary Medicine Content current as of: 08/06/2026 Regulated Product(s) Animal & Veterinary