FDA expands monthly parasiticide label

Photo: AK ST/Adobe Stock

Officials with the FDA have approved a new indication for a monthly fluralaner chewable tablet (Bravecto 1-Month; Intervet and Merck Animal Health). The expanded use of the 1-month formation now includes treatment and control of Asian longhorned tick (Haemaphysalis longicornis) infestation for 1 month in canines ages 8 weeks and older weighing 4.4 lbs or more.¹

This parasiticide product was previously approved for killing adult fleas (Ctenocephalides felis), treating and preventing flea infestations, and treating and controlling infestations of the black-legged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), and brown dog tick (Rhipicephalus sanguineus) for 1 month in canines ages 8 weeks and older and weighing at least 4.4 lbs. Additionally, this fluralaner chewable tablet is FDA-approved for treating and controlling lone star tick (Amblyomma americanum) infestation for 1 month in canines ages 6 months and older, weighing 4.4 lbs or more.²

“Parasites pose serious animal and human health risks as fleas and ticks can transmit disease agents,” Kathryn Duncan, DVM, PhD, DACVM, parasitology field specialist at Merck Animal Health, said in a news release.³ “Protection against the Asian longhorned tick is critical because its prevalence is increasing throughout the country.”

In early 2023, Merck Animal Health also announced FDA approval of use of fluralaner chewable tablet (Bravecto for Dogs) for 12 weeks with Asian longhorned tick infestation. That expanded product label also includes protection against flea, black-legged tick, American dog tick, and brown dog tick infestations for 12 weeks; and 8 weeks for lone star tick infestations.³

In a dose confirmation study for use of 1-month fluralaner chewable tablet against Asian longhorned ticks on puppies in South Africa, 18 healthy dogs were enrolled. These puppies were randomly assigned to either receive fluralaner treatment or placement in the untreated control group. Each dog was infested with approximately 50 adult Asian longhorned ticks on Day 2 and weekly, Day 7 through Day 28. Tick counts were conducted weekly, Day 2 through Day 30.²

Investigators found those treated with the 1-month fluralaner product had greater than 90% reduction in live tick counts at 48 hours following administration of the drug or infestation for 30 days than dogs treated in the control group. Overall, the study demonstrated that fluralaner chewable tablets were effective for reducing live Asian longhorned ticks and increasing dead Asian longhorned ticks for 1 month. Furthermore, no adverse reactions were reported in this investigation, according to the FDA.²

One-month fluralaner chewable tablets are available in 5 strengths with a minimum dose of 4.5 mg/lb. The drug is administered orally once a month with food and is required to be dispensed or prescribed by a veterinarian.²

In addition to the expanded FDA approval for 1-month fluralaner chewable tablets, Merck Animal Health recently announced marketing authorization from the European Union (EU) for a new, 3-in-1 fluralaner formulation (Bravecto TriUNO) that targets flea and ticks as well as roundworms, hookworms and heartworms in canines. This tablet includes moxidectin and pyrantel as active ingredients, and will be available in the EU through licensed veterinarians. It has also been approved by agencies in Peru, Guatemala, Nicaragua, and Costa Rica.⁴

“Merck Animal Health is committed to enabling more convenient options for comprehensive parasitic protection for pets and their owners,” Jason Drake, DVM, DACVM, parasitology director, scientific marketing affairs, global companion animal parasiticides at Merck Animal Health, said in a news release.⁴ “This new addition to our BRAVECTO portfolio provides easy-to-administer protection for pets against a broader range of parasites. While most pet owners understand the importance of protection against fleas and ticks, it’s equally important to protect pets from internal parasites as both can lead to further health issues and disease. With a single medication, pet owners can feel assured their pets are protected from all sides.”

References

1. Recent animal drug approvals. FDA. December 2, 2024. Accessed December 2, 2024. https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/recent-animal-drug-approvals?utm_medium=email&utm_source=govdelivery
2. Freedom of Information Summary, NADA 141-532. FDA. November 25, 2024. Accessed December 2, 2024. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16308
3. Merck Animal Health receives US FDA approval of expanded indication for Bravecto (fluralaner) Chews for Dogs. News release. Merck Animal Health. January 26, 2023. Accessed December 2, 2024. https://www.merck-animal-health.com/blog/2023/01/26/merck-animal-health-receives-u-s-fda-approval-of-expanded-indication-for-bravecto-fluralaner-chews-for-dogs/
4. Merck Animal Health announces European approval of Bravecto TriUNO for use in dogs. News release. Merck Animal Health. November 26, 2024. Accessed December 2, 2024. https://www.merck-animal-health.com/blog/2024/11/26/european-approval-of-bravecto-triuno/