Thursday, November 21, 2024 11/21/2024

Concentration Determination of Tulathromycin Residues (CP-60,300) in Liver and Injection Site Tissues of Goats Receiving One Subcutaneous Injection of DRAXXIN 25 (25 mg/mL) at 2.5 mg/kg Bodyweight

Award Number: R01FD008252
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY This project aims to address the significant problem of bacterial pneumonia in goats, which is a major cause of morbidity and mortality and represents a significant welfare challenge for operations in the United States. Currently, there is only one FDA-approved antibiotic for the treatment of respiratory disease in goats, which requires daily administration. That decreases efficacy in situations where owner compliance with labeled instructions is lacking. To address this problem, the proposed research aims to determine an appropriate withdrawal period following administration of Draxxin® 25 in goats except breeding and lactating goats. The expected outcome is to have quantified data from incurred liver and injection site tissues that can be utilized to determine a meat withdrawal period. Following completion of this work, we will have completed all the work associated with all the necessary technical sections which we be able to submit to FDA CVM for consideration for a label approval. The label approval of Draxxin® 25 will make it easier for veterinarians to use tulathromycin in goats with confidence in scientifically based labeled slaughter withdrawal times.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $250,000 )
2024	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Food and Drug Administration Research	001	1	9/23/2024	NEW	$0
2024	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Food and Drug Administration Research	000	1	9/2/2024	NEW	$250,000
														Subtotal = $250,000

Grand Total All Awards = $250,000

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Concentration Determination of Tulathromycin Residues (CP-60,300) in Liver and Injection Site Tissues of Goats Receiving One Subcutaneous Injection of DRAXXIN 25 (25 mg/mL) at 2.5 mg/kg Bodyweight

Award Number: R01FD008252

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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