FDA approves first animal drug for wild quail

Photo: Tyler/Adobe Stock

Officials with the FDA recently issued a supplemental approval for fenbendazole (Safe-Guard; Intervet) for the treatment and control of gastrointestinal worms (Aulonocephalus spp) in wild quail. Although 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. Fenbendazole was previously approved for treatment of certain intestinal parasites in other animal species, including cattle, swine, and turkeys.

The FDA’s mission is to protect and promote the health of both humans and animals, including those animals that are considered minor species such as sheep, goats, and ferrets as well as zoo animals and wildlife including wild quail. The supplemental approval of fenbendazole provides a tool for wildlife managers to treat and control these parasites in wild quail populations, according to the FDA.

Some of the studies that supported the approval of fenbendazole 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 in Lubbock. 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 4 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 fenbendazole is used according to the labeling.

Fenbendazole is available over the counter and is supplied in 25-pound bags. Wild quail should be administered 90.7g of fenbendazole/ton of Type C medicated feed, to be fed for 21 consecutive days.

Reference

FDA approves first drug for use in wild quail. FDA. News release. May 23, 2024. Accessed June 10, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-drug-use-wild-quail?utm_medium=email&utm_source=govdelivery