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U.S. Department of Health and Human Services

Animal & Veterinary

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PMF 005-499 - Letter

December 7, 1994

PMF 5499 A-0000

Linda G. Kahn, D.V.M.
FDA Liaison to the NRSP-7
HFV-130
Center for Veterinary Medicine
7500 Standish Place
Rockville, Maryland 20855

Dear Dr. Kahn:

We refer to your submissions to the public master file (PMF 5462) dated May 3,1994, (A0000) and August 11,1994, (C-OOOI), for the use of Ivermectin for the treatment and
control of various nematodes in red deer. This submission contains for review drug efficacy and target animal safety data and a Freedom of Information Summary.

We have reviewed your submissions and have the following comments.

TARGET ANIMAL SAFETY/DRUG EFFICACY - Complete

The data you have submitted supports the claim that Ivermectin is safe and effective for the treatment and control of the following gastrointestinal nematodes namely, Trichostrongylus spp. (adults), Oesophagostomum spp. (adults), Haemonchus spp. (adults), Spiculopteragia spp. (adults) in red deer.

FREEDOM OF INFORMATION SUMMARY(FOI) - Incomplete

Please revise your FOI efficacy section to provide for the following nematodes and their percent efficacy:

NematodeControl No.Treatment No.% Efficacy
 
Trichostrongylus spp. (adults)12,4806099.5%
 
Oesophagostomum spp. (adults)6000100.0%
Haemonchus spp. (adults)1,7802098.9%
Spiculopteragia spp. (adults)5600100.0%

OTHER CONSIDERATIONS

Please be aware that the human food safety, the manufacturing and the environmental components of your submission are outstanding.

Future correspondence regarding this letter should reference our file number, PMF 5499 A-0000 and C-0001, and be addressed to the Document Control Unit, HFV-199.

If you have any questions regarding this correspondence, please telephone Dr. Melanie Berson, Chief, Antiparasitic and Physiologic Drugs Branch at (301) 594-1643.

Sincerely yours,

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