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Animal & Veterinary

FDA Approves Drug to Assist with Cattle Breeding Regimens

February 25, 2013

The U.S. Food and Drug Administration announced today the approval of GONAbreed (gonadorelin acetate) to be used with another drug (cloprostenol) for use in timed breeding regimens in cattle. The approval is the first in the U.S. of a gonadorelin for use with a prostaglandin to synchronize reproductive cycles to allow for fixed time artificial insemination in lactating dairy cows and beef cows.

Gonadorelin and cloprostenol are versions of gonadotropin-releasing hormone and prostaglandin. Gonadotropin-releasing hormone and prostaglandin are naturally present in the cow and regulate the reproductive cycle. The use of these drugs in timed breeding regimens, along with other management practices, allow farmers to breed cows based on a consistent schedule, rather than having to breed animals based on physical observation, thereby improving the efficiency by which producers can breed their cattle.

Evidence of the safety and effectiveness of GONAbreed, used in conjunction with cloprostenol, was demonstrated in two multi-center clinical field studies. The studies indicated increased pregnancy rate to fixed time insemination compared with control cows given cloprostenol alone.

There were no reported adverse events associated with the use of gonadorelin and cloprostenol during the clinical field studies.

GONAbreed is manufactured by Parnell Technologies Pty. Ltd., Australia and distributed by Parnell U.S. 1, Inc. of Kansas City, Kansas.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7519 Standish Place, HFV-1

Rockville, MD 20855

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