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FDA Approves First Drug for Use in Wild Quail

May 23, 2024

Today the U.S. Food and Drug Administration issued a supplemental approval for Safe-Guard (fenbendazole) for the treatment and control of gastrointestinal worms (Aulonocephalus spp.) in wild quail. This approval provides a tool for wildlife managers to treat and control these parasites in wild quail populations. While there are currently FDA-approved drugs for use in farmed quail, this is the first animal drug approval for use in wild quail and for this indication.

The FDA’s mission is to protect and promote the health of both humans and animals, including those animals that are considered “minor species” – animals other than those typically thought of as livestock (cattle, pigs, chickens, turkeys) or companion animals (dogs, cats, horses). Minor species are animals that may not be quite so common – such as sheep, goats, and ferrets, but also zoo animals and wildlife, such as wild quail. 

Some of the studies that supported the approval of Safe-Guard in wild quail were conducted by the Minor Use Animal Drug Program (formerly National Research Support Project-7), in collaboration with researchers from Texas Tech Wildlife Toxicology Laboratory. As a partnership between the FDA, USDA, and university researchers, the Minor Use Animal Drug Program is a public research organization that generates scientific data to support FDA approval of new animal drugs for minor species of agricultural importance. The program works to complete four of the technical sections required for approval: effectiveness, target animal safety, human food safety, and environmental impact. Pharmaceutical sponsors can then use this information along with their own manufacturing and labeling information to apply for a new animal drug approval. By providing an official liaison to the Minor Use Animal Drug Program, the FDA gives technical and regulatory support to the university researchers who conduct the studies, helping to facilitate the approval of safe and effective drugs for minor agricultural species.

In addition to determining that fenbendazole is safe and effective, the FDA determined that there is a reasonable certainty of no harm for residues of fenbendazole in the edible tissues of treated quail following human consumption when Safe-Guard is used according to the labeling.

Wild quail should be administered 90.7g of fenbendazole/ton of Type C medicated feed, to be fed for 21 consecutive days.

Safe-Guard is available over-the-counter and is supplied in 25-pound bags. 

Safe-Guard was previously approved for treatment of certain intestinal parasites in other animal species, including cattle, swine, and turkeys. The application is sponsored by Intervet, Inc. based in Rahway, New Jersey.

For more information:

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

 
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