FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duration

Vicki · Jun 4, 2014

FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duration

Approval marks second animal drug approval under collaborative initiative with Canada

June 3, 2014

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced today the approval of BRAVECTO (fluralaner) Chewable Tablets for Dogs, the first oral flea and tick medication that lasts up to 12 weeks. The drug treats and prevents fleas for 12 weeks; treats and controls three types of ticks—the brown dog tick, American dog tick and deer tick—for 12 weeks; and treats and controls the lone star tick for 8 weeks.

The approval of BRAVECTO is in cooperation with Health Canada’s Veterinary Drugs Directorate (VDD), under the Regulatory Cooperation Council (RCC) joint initiative which aims to better align the approval process for these products. While maintaining safety standards, the RCC is intended to speed access to products, eliminate duplication, and reduce regulatory obstacles that can slow trade and investment opportunities as well as add costs to manufacturers and consumers. Under this initiative, FDA and VDD allow simultaneous submissions and collaborative reviews where possible, while maintaining each country’s right to decide whether or not products will be approved for its market.
The product is being marketed by Intervet Inc. and requires a valid prescription from a veterinarian for its use.

FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duration

TDK · Jun 4, 2014

Re: FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duratio

No mention of any side effects? Kinda weird.

pejay · Apr 19, 2015

Re: FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duratio

Margin of Safety Study:
In a margin of safety study, Bravecto was administered orally
to 8- to 9-week-old puppies at 1, 3, and 5X the maximum label dose of 56 mg/kg at
three, 8-week intervals. The dogs in the control group (0X) were untreated.
There were no clinically-relevant, treatment-related effects on physical examinations,
body weights, food consumption, clinical pathology (hematology, clinical chemistries,
coagulation tests, and urinalysis), gross pathology, histopathology, or organ weights.
Diarrhea, mucoid and bloody feces were the most common observations in this study,
occurring at a similar incidence in the treated and control groups. Five of the twelve
treated dogs that experienced one or more of these signs did so within 6 hours of the
first dosing. One dog in the 3X treatment group was observed to be dull, inappetant,
with evidence of bloody diarrhea, vomiting, and weight loss beginning five days
after the first treatment. One dog in the 1X treatment group vomited food 4 hours
following the first treatment.
Reproductive Safety Study:
Bravecto was administered orally to intact, reproductively-
sound male and female Beagles at a dose of up to 168
mg/kg (equivalent to 3X the
maximum label dose) on three to four occasions at 8-week intervals. The dogs in the
control group (0X) were untreated.
There were no clinically-relevant, treatment-related effects on the body weights, food
consumption, reproductive performance, semen analysis, litter data, gross necropsy
(adult dogs) or histopathology findings (adult dogs and puppies). One adult treated
dog suffered a seizure during the course of the study (46 days after the second
treatment). Abnormal salivation was observed on 17 occasions: in six treated dogs
(11 occasions) after dosing and four control dogs (6 occasions).
The following abnormalities were noted in 7 pups from 2 of the 10 dams in only the
treated group during gross necropsy examination: limb deformity (4 pups), enlarged
heart (2 pups), enlarged spleen (3 pups), and cleft palate (2 pups). During veterinary
examination at Week 7, two pups from the control group had inguinal testicles, and
two and four pups from the treated group had inguinal and cryptorchid testicles,
respectively. No undescended testicles were observed at the time of necropsy
(days 50 to 71).
In a well-controlled field study
Bravecto was used concurrently with other medications,
such as vaccines, anthelmintics, antibiotics, and steroids. No adverse reactions were
observed from the concurrent use of Bravecto with other medications.
Click to expand...

Frontline also has Nexguard (afoxolaner) chewtabs now.

bull_dog_love · Apr 19, 2015

Re: FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duratio

I use trifexis and it didnt do anything for ticks and its monthly. If there is no bad side effects i can see us switching thanks for the great info

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FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duration

Vicki Administrator Staff Member

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FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duration

Vicki Administrator Staff Member

TDK CH Dog Staff Member

pejay Big Dog

bull_dog_love Pup

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