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U.S. Department of Health and Human Services

Animal & Veterinary

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PMF 005-639 - August 26, 2009 Effectiveness Letter

August 26, 2009

I-011669-P-0014-EF


U.S. Department of the Interior
Fish and Wildlife Service
Aquatic Animal Drug Approval Partnership Program
Attention: David Erdahl, Ph.D.
Branch Chief
4050 Bridger Canyon Road
Bozeman, MT 59715

Re: Effectiveness technical section complete

Dear Dr. Erdahl:

Based upon the information you submitted on February 26, 2009 (P-0014), and the information contained in the Investigational New Animal Drug file 011669 and the Public Master File 005639, the Division of Therapeutic Drugs for Food Animals considers the Effectiveness technical section to be complete. The technical section is complete for the use of hydrogen peroxide in freshwater-reared warmwater finfish for the control of mortality due to external columnaris associated with Flavobacterium columnare when administered at a dose of 50 to 75 mg/L in a continuous flow water supply or as a static bath for 60 minutes per day on three alternate days.

COMMENTS ON THE FINAL STUDY REPORT

  1. Tricaine methanesulfonate is a drug and its concurrent use during pivotal studies should be limited. The use of tricaine methanesulfonate was reported and we agree that it did not impact the conclusions about the effectiveness of hydrogen peroxide in this study. In future studies, please avoid the use of concurrent medications.
  2. Section 5.5.1 of the protocol states that “Blinded study participants will… perform necropsies on fish during the treatment and post-treatment periods of the study.” We noted that Mr. Michael Matthews, a non-blinded participant, conducted some of the fish necropsies during these times. Although we do not believe this impacted the study, it should have been reported as a deviation.

LABELING

We appreciate your cooperation in including the relevant portions of the draft label claim language with this submission. Based on information provided as All Other Information, we believe that a statement will need to be included on the label with regard to sensitivities of ornamental finfish to hydrogen peroxide.

ALL OTHER INFORMATION (AOI)

We appreciate your cooperation in providing AOI related to the Effectiveness technical section. In Russo et al. (2007), preliminary investigations found that even at very low concentrations, hydrogen peroxide appeared to be toxic to suckermouth catfish and blue gouramis. A statement on the label such as ‘Use with caution on ornamental finfish’ may be necessary.

FREEDOM OF INFORMATION (FOI) SUMMARY

We appreciate your cooperation in including the draft FOI Summary for the Effectiveness technical section. CVM has made some revisions and a copy of the draft Effectiveness section of the FOI Summary is enclosed. Please review the FOI Summary for accuracy and notify us if you find errors. If you request changes other than the correction of errors, CVM may re-open the Effectiveness technical section.

Include a copy of this technical section complete letter when you submit your NADA. 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.

Sincerely,

 

 

/s/
Cindy L. Burnsteel, DVM
Director, Division of Therapeutic
Drugs for Food Animals
Office of New Animal Drug Evaluation
Center for Veterinary Medicine


Enclosure:
Draft Effectiveness Section of the FOI Summary