NEW DRUGS APPROVED

U.S. Food and Drug Administration approved SimpleraOtic Solution, the first generic drug product that has a single dose treatment with a 30-day duration of effect for otitis externa (outer ear infection) in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Active ingredients- SimpleraOtic Solution contains the same active ingredients (florfenicol, terbinafine, mometasone furoate) in the same concentration and dosage form as the approved brand name drug product, Claro, which was first approved on September 20, 2015.

·        Simplera is a prescription product, meaning a veterinarian’s expertise is required to diagnose otitis externa and to determine whether Simplera is an appropriate treatment.

·        Dogs that are administered Simplera should be restrained to minimize post-application head shaking. People who are administering Simplera or restraining dogs should wear eye protection.

·        Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent eye injuries. Precautions should also be taken to prevent medication getting in the eyes of the dog being treated. If accidental exposure to the eyes of people or dogs occurs, seek medical care.

·        Simplera is supplied in a single-use dropperette in a blister. Each dropperette contains one 1 mL dose. Simplera is available in cartons of 10 dropperettes.

·        Simplera is sponsored by Vetoquinol USA, Inc., based in Fort Worth, Texas.

The drug is also approved to treat and control Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater.

Fluralaner is an ectoparasiticide belonging to the isoxazoline class. The drug inhibits the nervous system of arthropods, such as fleas and ticks. It works by blocking gamma-aminobutyric acid (GABA)- and glutamate-gated chloride channels. Chloride ions are blocked from crossing cell membranes, which results in uncontrolled neuromuscular activity in fleas and ticks, causing their death.

BRAVECTO® PLUS is already approved to prevent heartworm disease caused by Dirofilariaimmitis; treat infections with intestinal roundworms (Toxocaracati) and hookworms (Ancylostomatubaeforme); kill adult fleas (Ctenocephalides felis); treat and prevent flea infestations; and treat and control Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick) infestations for 2 months in cats and kittens 6 months of age and older and weighing 2.6 pounds or greater.

1.      Fluralaner is an ectoparasiticide belonging to the isoxazoline class. The drug inhibits the nervous system of arthropods, such as fleas and ticks. It works by blocking gamma-aminobutyric acid (GABA)- and glutamate-gated chloride channels. Chloride ions are blocked from crossing cell membranes, which results in uncontrolled neuromuscular activity in fleas and ticks, causing their death.

2.      Moxidectin is a parasiticide belonging to the macrocyclic lactone class. It is effective against intestinal parasites and larval stages of D. immitis. Moxidectin binds to and activates the parasites’ chloride channels, which causes increased permeability and an influx of chloride ions. This results in flaccid paralysis and death of the parasites.

Important Safety Information

BRAVECTO Topical Solution for Cats: The most commonly reported adverse reactions include vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. BRAVECTO Topical Solution for Cats is not effective against American dog ticks beyond 8 weeks of dosing. BRAVECTO Topical Solution has not been shown to be effective for 12-weeks’ duration in kittens less than 6 months of age.

BRAVECTO PLUS Topical Solution for Cats: The most commonly reported adverse reactions include vomiting, hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and hypersalivation. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Use with caution in cats that are heartworm positive.

·        The effectiveness of BRAVECTO PLUS to prevent heartworm disease after bathing or water immersion has not been evaluated.

·        BRAVECTO Topical Solution for Cats and BRAVECTO PLUS for cats are for topical use only. Avoid oral ingestion.

·        The safety of BRAVECTO Topical Solution for Cats and BRAVECTO PLUS have not been established in breeding, pregnant, and lactating cats.

·        The Nobivac® Intra-Trac® Oral BbPi proprietary oral formulation and revolutionary Immuno-Mist-R™ delivery system make oral protection against canine parainfluenza possible, at last.

·        The product’s unique Immuno-Mist-RTM Applicator provides extensive spray coverage that more efficiently delivers broad protection for dogs while significantly enhancing ease of use for veterinarians and veterinary technicians, and comfort for canine patients.

·        Nobivac Intra-Trac Oral BbPi is a ground-breaking addition to Merck Animal Health’s Intra-Trac respiratory portfolio.

·        Nobivac Intra-Trac Oral BbPi has been shown to be effective for vaccination of healthy dogs seven weeks of age or older against canine parainfluenza virus and Bordetella bronchiseptica.

·        The product is thimerosal-free and contains no preservatives. With this first-of-a-kind product, veterinarians and support staff can now offer clients dual protection against two major respiratory pathogens while providing a better vaccination experience for dogs.

·        In addition, the breakthrough technology of the Immuno-Mist-R applicator was instrumental in achieving an effective oral parainfluenza vaccine.

“For dogs in social environments, including parks, boarding kennels and daycares, co-infection of the respiratory tract with two or more pathogens is often observed,” said Madeleine Stahl, DVM, associate director medical affairs, Merck Animal Health.

“Given the role that Bordetella and parainfluenza play in the canine infectious respiratory disease complex, preventing the spread of both is critical to protect the respiratory health of social dogs and lessen the possibility of future outbreaks – and Nobivac Intra-Trac Oral BbPi does just that.”

Canine parainfluenza

·        Canine parainfluenza spreads rapidly among susceptible dogs that interact with one another frequently or are housed in close confinement, and is among the most common causes of highly contagious acute-onset cough in dogs throughout the world.

·        Because the virus is excreted from the respiratory tract of infected dogs for up to 10 days after infection and is transmitted through the air, it can quickly become difficult to control. 

Nobivac Intra-Trac Oral BbPi was designed to deliver mucosal immunity with a simple oral application that is more convenient for the veterinarian and less stressful for the pet and pet owner.

Luer lock syringes demarcated with green plungers and labeled “For use with NOBIVAC® INTRA-TRAC® ORAL BbPi,” as well as Immuno-Mist-R applicator tips will be provided with the purchase of each vaccine tray. Using the Luer lock syringes and Immuno-Mist-R tips, Nobivac Intra-Trac Oral BbPi is administered by gently misting the vaccine orally towards the back of the mouth.