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PMF 005-433 - 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 5433 C-0005

June 7, 1999

Meg 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) 5433 dated March 8, 1999, which provides data and information to demonstrate effectiveness, target animal safety, and human food safety for the use of amoxicillin trihydrate injection for the treatment of bacterial pneumonia due to Pasteurella spp. and Haemophilus spp. in sheep. The PMF also provides an environmental assessment that adequately addresses the potential impacts due to the use of the drug in sheep.

We have completed our review of the effectiveness, target animal safety, and human food safety data contained in this PMF, and conclude that these data are satisfactory to support those aspects of a new animal drug application (NADA) or supplemental NADA.

A notice of satisfactory data contained in this PMF will be published in the FEDERAL REGISTER. These data supplied by NRSP-7 (formerly IR-4), Western Region, 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, (1) animal drug labeling, (2) other data needed for approval, such as manufacturing methods, facilities, and controls, and (3) information addressing the potential environmental impacts (including occupational) of the manufacturing process.

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 5433 C-0005, and be submitted to the Document Control Unit, HFV-199.

If you have any questions regarding this correspondence, please contact Dr. George Haibel, Leader, Antimicrobial Drugs Team, at 301-827-7573.

Sincerely yours,

Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

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