Zoetis Receives FDA Approval for ProHeart® 12, the Only Once-Yearly Injection to Prevent Heartworm Disease in Dogs

ProHeart 12 (moxidectin) makes compliance easy for dog owners, eliminating gaps in protection for a full year for dogs 12 months of age and older

PARSIPPANY, N.J., July 16, 2019Zoetis today announced that the U.S. Food and Drug Administration (FDA) has approved ProHeart® 12 (moxidectin), the new once-yearly injection to prevent heartworm disease (caused by Dirofilaria immitis) in dogs 12 months of age and older. Its unique formulation of moxidectin microspheres provides long-lasting protection against heartworm disease and treats dogs for existing larval and adult hookworms (Ancylostoma caninum and Uncinaria stenocephala). ProHeart 12, which is administered at the veterinary clinic, makes compliance easy as there are no monthly doses to remember, so dog owners don’t have to worry about gaps in protection for a full year. 

"The convenience of once yearly dosing will provide my clients peace of mind, provide my patients uninterrupted protection, and allow me to be the ‘managing partner’ in a joint effort to prevent heartworm disease in dogs across America,” said Dr. Robert Gribble, DVM, CVPM, Hallsville Veterinary Hospital, Hallsville, Texas*. “Yearly wellness visits that include ProHeart 12 are the solution for my clients, and when I provide solutions, they are my clients forever."

In three robust studies, ProHeart 12 was 100 percent effective against heartworm disease.1 The active ingredient, moxidectin, which is released over 12 months, is contained in slow-dissolving microspheres that are stored in a dog’s adipose tissue.

“Dogs of all ages, breeds and lifestyles are susceptible to heartworm disease, which is a threat year-round and has been found in all 50 states,2” said Claire Walther, DVM, Veterinary Specialty Team, Zoetis Petcare. “ProHeart 12 is another example of Zoetis’ commitment to innovation and providing veterinarians with the best parasiticide options for their patients, helping to preserve the important bond between dogs and their owners.” 

Zoetis plans to start shipping ProHeart 12 to customers in early August. Veterinarians may now place advance orders directly online, by contacting their Zoetis representative or their Distributor representative, or by calling Customer Service at 1-888-Zoetis1 (1-888-963-8471). For more information about ProHeart 12, visit www.ProHeartDVM.com. To see full Prescribing Information, visit www.ProHeart12PI.com

About ProHeart 12 
ProHeart 12 is a veterinarian-administered injectable parasiticide for dogs that provides 12 months of heartworm disease prevention, as well as treatment for larval and adult hookworms (Ancylostoma caninum and Uncinaria stenocephala) existing at the time of administration. Just one injection protects dogs against heartworm disease for 12 full months, eliminating the need for monthly dosing.

IMPORTANT SAFETY INFORMATION
Use PROHEART 12 in dogs 12 months of age or older. Do not administer to dogs that are sick, debilitated, underweight, have a history of weight loss, or to those previously found to be hypersensitive to the drug. Hypersensitivity reactions may occur in some dogs when PROHEART 12 is administered alone or with vaccines. Anaphylactic and anaphylactoid reactions can result in death and should be treated immediately with the same measures used to treat hypersensitivity reactions to vaccines and other injectable products. The most common reported side effects in clinical trials were vomiting, lethargy, diarrhea, and anorexia. People should avoid inhalation, contact with eyes, or accidental self-injection. Certification is required before veterinarians and staff administer PROHEART 12. See full Prescribing Information for PROHEART 12. 

About Zoetis 
Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2018, the company generated annual revenue of $5.8 billion with approximately 10,000 employees. For more information, visit www.zoetis.com

*Dr. Robert Gribble has a consulting relationship with Zoetis.

For further information, contact:
Colleen White
973-822-7203
colleen.white@zoetis.com

Katelyn Kwiatkowski
973-588-2182
kkwiatkowski@coynepr.com

References:
1 Data on file, Study Reports A166C-US-14-362 and A166C-US-14-376, Zoetis, Inc.
2 Current canine guidelines for the prevention, diagnosis, and management of heartworm (Dirofilaria immitis) infection in dogs. American Heartworm Society. https://www.heartwormsociety.org/images/pdf/2018-AHS-Canine-Guidelines.pdf. Accessed March 20, 2019.

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