Feds approve drugs treating canine osteosarcoma, ornamental fish parasites

Since the beginning of this year, federal agencies have approved eight new animal drugs as treatments for a range of diseases, including bone cancer in dogs, white spot disease in pet fish, and respiratory disease in swine and cattle.

Elias Cancer Immunotherapy

The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) has approved Elias Cancer Immunotherapy (ECI), the first autologous prescription product approved for treating canine osteosarcoma, according to a March 19 statement from drug sponsor Elias Animal Health.

ECI works by first conditioning the immune system to recognize a patient’s unique cancer and then delivering activated killer T cells to target and attack those cancer cells. The decision to pursue ECI must be made prior to surgery. The reason being cancer tissue must be harvested from the patient and used to manufacture the treatment.

“Immunotherapies such as ECI are at the forefront of new treatment options which use the patient’s own immune system to fight their cancer,” said Dr. Noe Reyes, chief medical officer for Elias. “We are excited to bring the first licensed adoptive cell therapy to the veterinary community and provide clinicians with an important new treatment option.”

Last year, the CVB determined that data collected from one of the largest clinical trials conducted in canine oncology—and the first of its kind to evaluate adoptive cell therapy for treating cancer in canine patients—showed a reasonable expectation of efficacy.

EIC is administered by authorized treatment centers, of which there are 100 locations across the United States. Veterinarians interested in learning more so that they may inform their clients about this new cancer treatment option, or having their practice authorized as a treatment center, are encouraged to contact the Lenexa, Kansas-based company.

Faunamor

On April 8, the Food and Drug Administration (FDA) announced it is making legally available a treatment for Ichthyophthirius multifiliis, also known as “Ich” or “white spot disease,” in ornamental finfish, including those commonly kept in home aquariums and outdoor hobby ponds.

By adding Faunamor to its Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, the FDA is making it the only legal drug currently on the market to treat Ich.

Faunamor is an antiparasitic and antimicrobial manufactured by Aquarium Münster Pahlsmeier GmbH in Telgte, Germany. It contains three active ingredients: methylthionine chloride, malachite green oxalate, and acriflavine chloride immersion solution. The drug is available over the counter and is supplied in 20 mL and 100 mL glass bottles.

Ich affects many types of ornamental fish, including tropical fish, goldfish, and koi. The parasite that causes the disease is highly contagious and Ich outbreaks can kill all the fish in the tank, aquarium, or pond in a short time.

The indexing process for Faunamor included a safety and efficacy evaluation by an expert panel that determined the benefits of using the drug outweigh its risks to ornamental finfish. FDA scientists reviewed the findings of the qualified expert panel and agreed with their conclusions before adding the drug to the index.

Mometamax Single

The FDA has approved Mometamax Single, a one-dose treatment for dogs with otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa), manufacturer Merck Animal Health announced May 2.

Canine otitis externa is characterized by redness, swelling, and pain, and is one of the most common conditions treated in veterinary practice. Otitis externa most commonly manifests as an acute condition or as an acute flare-up of a recurrent condition, and symptoms to be aware of include odor, discharge, and constant head shaking.

Mometamax Single—a gentamicin, posaconazole, and mometasone furoate otic suspension—is administered as a topical suspension and the only one dose in-clinic product labeled to treat Pseudomonas aeruginosa. A single 0.8 mL is administered to the infected ear.

Daily treatment can be a challenge for busy owners, especially when their dog is suffering from a painful condition like otitis. In such cases, Mometamax Single offers an effective, convenient alternative, said Dr. Alison De Leon, director of global pharmaceutical development for MSD Animal Health.

Mometamax Single is expected to be available at veterinary clinics nationwide this summer.

Enrofloxacin Flavored Tablets

The FDA approved on March 24 Enrofloxacin Flavored Tablets, an antibiotic indicated for treating diseases associated with bacteria susceptible to enrofloxacin in dogs and cats.

The tablets are a generic version of Baytril and sponsored by Hikma Pharmaceuticals USA, located in Cherry Hill, New Jersey.

They are available with a prescription in 22.7 mg strength in bottles containing 100 or 500 double-scored tablets, 68 mg strength in bottles containing 50 or 250 double-scored tablets, or 136 mg strength in bottles containing 50 or 200 double-scored tablets.

For dogs, enrofloxacin tablets should be administered orally at 2.27-9.07 mg per lb (5-20 mg/kg) of body weight. For cats, the recommended dosage is 2.27 mg per lb (5 mg/kg) of body weight. The dosage for dogs and cats may be administered either as a single daily dose or divided into two equal daily doses given every 12 hours, for at least two to three days but no more than 30 days.

The FDA says dosage selection should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals that receive doses in the upper end of the dose range should be monitored for clinical signs that may include lack of appetite, depression, and vomiting.

MoxiCloprid

The FDA also approved on March 24 MoxiCloprid for Cats as a preventative against heartworm disease caused by Dirofilaria immitis, to kill adult fleas (Ctenocephalides felis), and as a treatment for flea infestations in cats. The agency also approved the topical antiparasitic as safe and efficacious for the same feline flea indications, but in ferrets.

Additionally, MoxiCloprid can be used to treat and control feline ear mite (Otodectes cynotis) infestations and the following intestinal parasites: hookworms (Ancylostoma tubaeforme) adult, immature adult, and fourth stage larvae; and roundworms (Toxocara cati) adult and fourth stage larvae.

The drug contains the same active ingredients—imidacloprid and moxidectin—in the same concentration and dosage form as the brand name drug, advantage multi for cats, first approved for use in cats in 2007 and for use in ferrets in 2013.

Sponsored by Bimeda Animal Health Ltd., in Oakbrook Terrace, Illinois, MoxiCloprid is available in applicator tubes of 0.23 mL, 0.4 mL, or 0.8 mL.

The drug is available by prescription from a licensed veterinarian and is administered topically at a recommended minimum dosage of 4.5 mg per lb (10.0 mg/kg) imidacloprid and 0.45 mg per lb (1.0 mg/kg) moxidectin, once a month. Each mL contains 100 mg of imidacloprid and 10 mg of moxidectin.

felycin-CA1

On March 14, the FDA granted conditional approval for felycin-CA1, sirolimus delayed-release tablets, for the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM).

Subclinical HCM refers to cats with left ventricular (LV) hypertrophy, but without systemic hypertension, other causes of compensatory myocardial hypertrophy, current or past symptoms of congestive heart failure, arterial thromboembolism, and severe LV outflow tract obstruction.

“Subclinical HCM often progresses to clinical HCM, which has a mortality and morbidity that substantially impact day-to-day functioning in cats. Therefore, the conditionally approved use of felycin-CA1 addresses a serious or life-threatening disease or condition,” according to the FDA. “The management of ventricular hypertrophy in cats with subclinical HCM is an unmet animal health need because there is no approved animal drug currently marketed in the United States for this use in cat.”

TriviumVet, an animal drug company based in Waterford, Ireland, is the sponsor of felycin-CA1, which is available in tablet form in strengths of 0.4 mg, 1.2 mg, and 2.4 mg with 12 tablets per carton. The drug is available by prescription only from a licensed veterinarian and administered to cats at a target dose 0.3 mg/kg orally once a week.

The active ingredient in felycin-CA1 is sirolimus, also known as rapamycin, a macrocyclic lactone produced by the bacterium Streptomyces hygroscopicus. At higher doses, sirolimus is used as an immunosuppressant in humans receiving organ transplants.

Tulathromycin injection for cattle and swine

The FDA approved on February 25 Tulathromycin Injection as a treatment for various bacterial diseases in beef cattle, nonlactating dairy cattle, suckling calves, dairy calves, veal calves, and swine.

In beef and nonlactating dairy cattle, Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Additionally, the injectable antimicrobial is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis and for bovine foot rot associated with Fusobacterium necrophorum and Porphyromonas levii.

In suckling calves, dairy calves, and veal calves, the drug is approved as a treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

And in swine, Tulathromycin Injection is approved as a treatment for swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with A. pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.

It contains the same active ingredient in the same concentration and dosage form as the approved brand name drug product, Draxxin, first approved for use in beef cattle, non-lactating dairy cattle, and swine in 2005, and suckling calves, dairy calves, and veal calves in 2014.

Sponsored by Hikma Pharmaceuticals, Tulathromycin Injection is available by prescription and supplied in 50 mL, 100 mL, 250 mL, and 500 mL vials with 100 mg of tulathromycin per mL.

Approved dosage regimens vary by species and circumstance. For cattle, the drug should be administered subcutaneously as a single dose in the neck at a dosage of 1.1 mL for each 100 lbs of body weight (2.5 mg/kg), and no more than 10 mL per injection site. For swine, it should be administered intramuscularly as a single dose in the neck at a dosage of 0.25 mL for each 22 lbs of body weight (2.5 mg/kg), and no more than 2.5 mL per injection site.

Eprimectin Pour-On

The FDA approved January 13 Eprimectin Pour-On, a generic eprinomectin topical solution, to treat and control gastrointestinal roundworms, including inhibited Ostertagia ostertagi; lungworms; grubs; sucking and biting lice; chorioptic and sarcoptic mange mites; and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle.

Sponsored by Bimeda Animal Health, Eprimectin Pour-On is available over the counter and supplied in 2.5- and 5-, liter backpack containers.

The drug contains the same active ingredient, eprinomectin, in the same concentration and dosage form as the brand-name drug product, Eprinex, which was approved for use in beef and dairy cattle, including lactating dairy cattle, in 1997.

The dose rate is 1 mL for each 22 lbs (10 kg) of body weight, and each mL contains 5 mg of eprinomectin. The product should be applied topically along the backline in a narrow strip extending from the withers to the tail head.