Announcement • 7h
Elanco Animal Health Announces Portfolio of Treatment Options and Expert Guidance Following First Confirmed Case of New World Screwworm in United States
Elanco Animal Health Incorporated reaffirmed its commitment to providing veterinarians, livestock producers, and pet owners with resources and treatment options for their animals against the escalating threat posed by New World screwworm (NWS). The fly recently reached the United States, with the first case confirmed in U.S. livestock in Texas. Elanco offers a portfolio of options for both livestock and pets that can treat infestations caused by New World screwworm larvae. With more than 70 years of animal health experience, including helping mitigate, prevent and treat New World screwworm in other parts of the world, Elanco is working alongside the U.S. animal health industry to help them fight against this parasite, offering a portfolio of options for pets and livestock that can help treat New World screwworm larvae infestations. Available Elanco Treatment and/or Prevention Options: Product Name: Credelio Quattro™-CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), Indication: Treats New World screwworm larvae infestations, Species: Dogs, Regulatory Status: FDA Conditional Approval. Product Name: Credelio™ (lotilaner), Indication: Treats New World screwworm larvae infestations, Species: Dogs, Regulatory Status: FDA Emergency Use Authorization (EUA). Product Name: Credelio™ CAT (lotilaner), Indication: Treats New World screwworm larvae infestations, Species: Cats, Regulatory Status: FDA Emergency Use Authorization (EUA). Product Name: Negasunt™ Powder (coumaphos, propoxur, and sulfanilamide topical powder), Indication: Treats and Prevents New World screwworm larvae infestations, Species: Variety of Livestock and other Species, Regulatory Status: FDA Emergency Use Authorization (EUA). Product Name: Tanidil™ (Coumaphos, Propoxur), Indication: Prevents and Controls New World screwworm larvae infestations, Species: Variety of Livestock and other Species, Regulatory Status: EPA Section 18 Emergency Exemption. Product Name: Catron® IV (Permethrin), Indication: Kills and controls screwworm fly and maggots, Species: Livestock, Regulatory Status: EPA Approved. Negasunt Powder and Tanidil will be available only through the U.S. Animal Plant Health and Inspection Service (APHIS) and its National Veterinary Stockpile. They will be distributed in coordination with state animal health officials and federally recognized tribal agencies. In the near future, APHIS will share additional information about the requirements for use, including tracking and reporting requirements and required safety and personal protective equipment. As New World screwworm enters the United States, Elanco is committed to working alongside producers as they continuously evolve management practices and to help them implement prevention and treatment protocols to use the right product at the right time. Credelio Quattro is indicated for the prevention of heartworm disease and the treatment and control of roundworm, hookworm, and tapeworm infections. Credelio Quattro kills adult fleas and is indicated for the treatment and prevention of flea infestations and the treatment and control of tick infestations for 1 month in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater. Credelio Quattro is indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks. Credelio Quattro-CA1 is conditionally approved for the treatment of infestations caused by New World screwworm (NWS) larvae in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater. Lotilaner, an ingredient in Credelio Quattro/Credelio Quattro-CA1, belongs to the isoxazoline class and has been associated with neurologic adverse reactions like tremors, incoordination, and seizures even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Dogs should be tested for existing heartworm infections before Credelio Quattro/Credelio Quattro-CA1 administration as it is not effective against adult heartworms. The safe use in breeding, pregnant, or lactating dogs has not been evaluated. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. Credelio Quattro-CA1 is conditionally approved by the FDA pending a full demonstration of effectiveness under application number 141-619. If you suspect that your dog is infested with NWS larvae, seek veterinary care immediately for treatment to include removal of larvae and appropriate wound care. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the approved product Credelio (lotilaner) chewable tablets for the treatment of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies. Credelio (lotilaner) is not approved for this use. Credelio (lotilaner) is approved for other uses in dogs and puppies. Credelio (lotilaner) chewable tablets is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Credelio (lotilaner) chewable tablets under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Credelio kills adult fleas and is indicated for the treatment and prevention of flea infestations and treatment and control of tick infestations (lone star tick, American dog tick, black-legged tick, brown dog tick, and longhorned tick) for one month in dogs and puppies 8 weeks and older and 4.4 pounds or greater. Credelio is indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks. Lotilaner is a member of the isoxazoline class of drugs. This class has been associated with neurologic adverse reactions including tremors, incoordination, and seizures. Seizures have been reported in dogs receiving this class of drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safe use of Credelio in breeding, pregnant or lactating dogs has not been evaluated. The most frequently reported adverse reactions are weight loss, elevated blood urea nitrogen, increased urination, and diarrhea. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the approved product Credelio CAT (lotilaner) for the treatment of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) in cats and kittens. Credelio CAT is not approved for this use.