PMF 003-883 - 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.

March 20, 1989

PMF 3883

Emilio E. Viera, D.V.M.
FDA Liaison to IR-4 Project
Division of Therapeutic Drugs
  for Food Animals, HFV-130
Center for Veterinary Medicine
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Viera:

This refers to your Public Master File (PMF) 3883 dated December 9, 1983, and all your amendments to this PMF up until June 27, 1988.

This PMF provides data and information to demonstrate effectiveness, target animal safety and human food safety of ivermectin injection for the treatment and control of gastrointestinal nematodes in goats.

We have completed our review of the effectiveness, target animal safety and human food safety 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 the 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 Public Master File, drug labeling, and other information needed for approval, such as, data concerning manufacturing methods, facilities, controls, and information addressing the potential environmental impacts of the manufacture and use of the drug product.

Sincerely yours,

/s/
Gerald B. Guest, DVM
Director, Center for Veterinary Medicine