PMF 005- 165 Target Animal Safety Letter

On September 3, 2021, a Target Animal Safety technical section complete letter, I-006013-P-0157-TS, was issued to the Minor Use Animal Drug Program (MUADP). The target animal safety technical section was considered to be complete for the use of erythromycin thiocyanate Type A medicated article in freshwater salmonids.

TARGET ANIMAL SAFETY

The technical section complete letter represents CVM’s finding that the information essential to determining target animal safety are complete and accepted. CVM also evaluated target animal safety in the review of other technical sections, particularly the Effectiveness and All Other Information technical sections.

DRAFT LABELING

CVM reviewed the draft labeling related to target animal safety. The language was revised. The following should be incorporated in the caution or other appropriate section of the labeling for the Labeling technical section.

Reduce handling or external stressors of fish during and for up to one month post administration. Handling of fish receiving erythromycin may result in death. Signs of erythromycin toxicity include reduced appetite and/or inappetence, tetany, muscle spasms, abnormal swimming, or increased mortality. Stop administration if signs of toxicity are seen.

ALL FURTHER TARGET ANIMAL SAFETY INFORMATION

Any additional information pertaining to Target Animal Safety of erythromycin thiocyanate Type A medicated article in freshwater salmonids should be submitted with the AOI technical section.

Include a copy of this technical section complete letter when submitting the new animal drug application. CVM will make a final decision on whether CVM can approve the application after reviewing all of the data for all applicable technical sections and any other information available to us, as a whole, and determined whether the requirements for approval described in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) have been met.