FDA grants Elanco emergency authorization for screwworm wound spray
Elanco Animal Health Incorporated (NYSE: ELAN) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its CLiK Extra (dicyclanil topical suspension) wound spray to prevent New World screwworm infestations in a range of livestock and wildlife species.
The authorization covers use of CLiK Extra on or around wounds in sheep, cattle, goats, swine, and camelids, as well as captive and captured cervids, American bison, bighorn sheep, and Sonoran pronghorn. The product is intended to prevent infestations of New World screwworm larvae before they occur, including wounds associated with birth and surgical procedures.
CLiK Extra has not been shown to treat active screwworm infestations. If a wound is already infested or an infestation develops after application, alternative treatment is required. The product will be available through standard animal health product channels.
The USDA confirmed the reentry of New World screwworm into the United States in June. The parasite's larvae consume the living flesh of warm-blooded hosts, posing a risk to livestock, wildlife, companion animals, and humans.
Elanco also holds emergency authorizations for two other screwworm-related products. Negasunt Powder (coumaphos, propoxur, and sulfanilamide topical powder) and Tanidil received earlier emergency authorizations for prevention and treatment of New World screwworm. Both products are available only through the U.S. Animal and Plant Health Inspection Service and its National Veterinary Stockpile, distributed in coordination with state animal health officials and federally recognized tribal agencies.
Elanco additionally offers Catron IV, an EPA-registered spray labeled for treatment against screwworm in beef and dairy cattle, sheep, goats, hogs, and horses.
Animals treated with CLiK Extra must not be slaughtered for human consumption within 86 days of treatment. The product is not for use in animals producing milk for human consumption, and a withdrawal period has not been established for pre-ruminating calves.
