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PMF 005-117 - 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.

September 1, 1989

PMF 5117

John G. Babish, Ph.D.
Associate Professor of Toxicology
  and Pharmacology
IR-4 Project, Northeast Regional Drug Coordinator
New York State College of Veterinary Medicine
Cornell University
Ithaca, NY 14853

Dear Dr. Babish:

This refers to your Public Master File (PMF) 5117 dated September 22, 1986, and all your amendments to this PMF up until March 3, 1989.

This PMF provides data and information concerning effectiveness, target animal safety, tissue depletion, and environmental assessment of levamisole hydrochloride oral drench for the treatment and control of gastrointestinal nematodes in goats.

We have completed our review of the effectiveness, target animal safety, tissue depletion and the environmental assessment data contained in this PMF, and the data are satisfactory upon which to base the approval of an NADA or supplemental NADA.

A notice of satisfactory data contained in this PMF will be published in the FEDERAL REGISTER. These data supplied by IR-4 were obtained with public funds and are, therefore, available for public disclosure and use by any sponsor.

An NADA or supplemental NADA should include, in addition to a reference to the PMF, drug labeling, and other information needed for approval, such as data concerning human food safety, manufacturing methods, facilities and controls, and information addressing the potential environmental impacts of the manufacturing process of the drug product.

Sincerely yours,

Gerald B. Guest, D.V.M.
Director Center for Veterinary Medicine

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