PMF 005-639 - October 12, 2011 Effectiveness Letter
October 12, 2011
U.S. Geological Survey
Upper Midwest Environmental Sciences Center
Attention: Mark P. Gaikowski
Interim Registration Officer
2630 Fanta Reed Road
La Crosse, WI 54603
Re: Effectiveness technical section complete
Dear Dr. Gaikowski:
Based upon the information you submitted on April 14, 2011, and amended on May 13, 2011 (T-0097) and the information contained in the investigational new animal drug (INAD) file I-010023, we consider the Effectiveness technical section to be complete. The technical section is complete for the use of 35% PEROX-AID (hydrogen peroxide) for the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae when administered at a dose of 75 mg/L for 60 minutes per day on alternate days for three treatments.
We consider 75 mg/L to be the lowest dose that is supported for an all freshwater finfish claim because it is the lowest dose with demonstrated effectiveness in all three temperature groups. Your cover letter proposed a dose range of 50-100 mg/L for all finfish. If you feel that the dose range should include a low dose of 50 mg/L, please provide us with justification for the effectiveness of this dose in warmwater fish. This justification should be supported with published literature, INAD or PMF information, or other supporting data. In your justification, please reference any files previously submitted to CVM that are relevant.
In future final study reports, please include curriculum vitae for all study personnel involved in the trial.
We note that you did not submit draft labeling. Please submit your labeling technical section when the last major technical section has been submitted and is likely to be complete. In the future, please include draft labeling with each major technical section.
ALL OTHER INFORMATION (AOI)
We note that you did not submit additional information pertaining to Effectiveness in this submission. In the future, please include the available relevant AOI with each technical section, or note in your cover letter that there is no AOI pertaining to the technical section. Please submit your AOI technical section, containing any additional information not previously submitted, when the last major technical section has been submitted and is likely to be complete.
FREEDOM OF INFORMATION (FOI) SUMMARY
We appreciate your cooperation in including the relevant portions of the FOI Summary with this submission. We have revised the Effectiveness section of the FOI Summary and a copy is enclosed. Please review the FOI Summary for accuracy and notify us if you find errors. We will prepare the final version of the FOI Summary and will provide you with a copy after the last technical section is complete.
Include a copy of this technical section complete letter when you submit your new animal drug application. Please contact us if there are changes in the product development plan (e.g., indication, dosage, duration of use) or you become aware of any issues that may impact the status of this technical section or your application. We will make a final decision on whether we can approve your application after we have reviewed 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 have been met.
If you submit correspondence relating to this letter, your correspondence should reference the date and the principal submission identifier found at the top of this letter. If you have any questions or comments, please contact me at (240) 276-8341. You may also contact Dr. Jennifer Matysczak, Leader, Aquaculture Drugs Team, at (240) 276-8338.
Cindy L. Burnsteel, DVM
Director, Division of Therapeutic
Drugs for Food Animals
Office of New Animal Drug Evaluation
Center for Veterinary Medicine
Draft Section of Freedom of Information (FOI) Summary: Effectiveness