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PMF 005-644 - Effectiveness Letter

The contact information provided in this letter may no longer be valid due to the passage of time. If you have questions about any of the PMFs in development, please contact AskCVM@fda.hhs.gov.

PMF 005644 A-0000

February 15, 2000

Margaret R. Oeller, D.V.M.
FDA Liaison to NRSP-7
Division of Therapeutic Drugs for Food Animals
Office of New Animal Drug Evaluation
Center for Veterinary Medicine
7500 Standish Place
Rockville, Maryland 20855

Dear Dr. Oeller:

We refer to your Public Master File (PMF) 5644 dated January 4, 1999, which provides data and information to demonstrate effectiveness for the use of fenbendazole 20% Type A medicated article for the treatment of Heterakis gallinae, Syngamus trachea, and Capillaria spp. in pheasant, quail, and partridge. The submission contains data from a dose confirmation study. Also, you included a draft Freedom of Information (FOI) Summary for the effectiveness technical section.

We have reviewed this submission and have the following comments.

The following claims are supported by the data:

In Pheasant for treatment of adult Heterakis gallinae and adult Syngamus trachea
In Quail for treatment of adult Heterakis gallinae and adult Capillaria spp
In Partridge for treatment of adult Heterakis gallinae

The draft FOI Summary is adequate.

Based on the information in this submission, the Division of Therapeutic Drug for Food Animals considers the Effectiveness technical section to be complete. A final decision on the approval of the application will be made when all data for the technical sections are viewed as a whole and it is determined that the information contained in and referenced by the application support approval. In submitting the original New Animal Drug Application (NADA), the sponsor should refer to the above document number and date, and include a copy of this correspondence in your submission at SECTION 8 EVIDENCE TO ESTABLISH SAFETY AND EFFECTIVENESS.

Future correspondence regarding this submission to the file for your PMF should be identified by the date of this correspondence and our file number, PMF 005-644 A-0000, and be submitted to the Document Control Unit, HFV-199.

If you have any questions regarding this correspondence, please contact Dr. Janis R. Messenheimer, Leader, Antiparasitic and Physiologic Drugs Team, at 301-827-7578.

Sincerely yours,

Steven D. Vaughn, D.V.M.
Director, Therapeutic Drugs for Food Animals
Office of New Animal Drug Evaluation
Center for Veterinary Medicine

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