United States

Zoetis Receives FDA Approval for DIROBAN™ (melarsomine dihydrochloride) to Treat Heartworm Disease in Dogs

PARSIPPANY, N.J. – Feb. 21, 2017 – Zoetis today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for DIROBAN™ (melarsomine dihydrochloride), a treatment for dogs infected with Dirofilaria immitis—the cause of heartworm disease. DIROBAN is now commercially available to veterinarians in the United States. DIROBAN has the same active ingredient as the only other FDA-approved adulticidal heartworm treatment, which has experienced intermittent supply shortages.1 With the introduction of DIROBAN, Zoetis now offers veterinarians a full canine heartworm product portfolio (prevention, detection, treatment) that aligns with the company’s Lifelong Care strategy.

Melarsomine dihydrochloride, the preferred method for treating canine heartworm disease, is recommended by both the American Heartworm Society and the Companion Animal Parasite Council™.2-4 Zoetis has been monitoring the supply of melarsomine dihydrochloride in the market and, in response, has introduced DIROBAN, which is manufactured at its FDA-approved facility to provide reliable access for veterinarians, their clients and their patients.

“Every dog that tests positive for heartworm disease should have access to the best treatment,” said Dr. Shelley Stanford, group director, Companion Animal Veterinary Professional Services at Zoetis. “Veterinarians can now depend on Zoetis and DIROBAN for the treatment of heartworm disease in their patients. This is one more example of our commitment to help pet owners and the dogs they love receive the standard of care that is best for long-term health.”

Following American Heartworm Society and Companion Animal Parasite Council guidelines, dogs that have stabilized Class 1, 2 or 3 heartworm disease should receive three doses of DIROBAN.3-4 Laboratory and clinical field trials show that treatment with DIROBAN results in the reduction and/or clearance of D. immitis infection.5

DIROBAN is now available to U.S. veterinarians. To learn more information, visit DirobanDVM.com or contact your Zoetis representative.

IMPORTANT SAFETY INFORMATION: DIROBAN is for use in dogs only. Do not use in dogs with very severe (Class 4) heartworm disease. Avoid human exposure. Consult a physician in cases of accidental human exposure by any route. DIROBAN should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 – L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Safety for use in breeding, pregnant or lactating animals has not been determined. Common side effects include injection site irritation (accompanied by pain, swelling, tenderness and reluctance to move), coughing/gagging, depression/lethargy, anorexia/inappetence, fever, lung congestion and vomiting. All patients should be monitored during treatment and for up to 24 hours after the last injection. See full Prescribing Information for additional safety information and precautions.

About Zoetis
Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products, genetic tests, biodevices 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 2016, the company generated annual revenue of $4.9 billion with approximately 9,000 employees. For more information, visit www.zoetis.com.

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

Lindsey Goodman
706-201-6721
lgoodman@archermalmo.com

References:
1 Current drug shortages. U.S. Food and Drug Administration. http://www/fda/gov/animalVeterinary/safetyhealth/productsafetyinformation/ucm267669. Accessed October 4, 2016.
2 Heartworm treatment study, May 2015. Ipsos Agricultural and Animal Health. 2015 Zoetis LLC.
3 Current canine guidelines for the prevention, diagnosis, and management of heartworm (Dirofilaria immitis) infection in dogs. American Heartworm Society. https://heartwormsociety.org/images/pdf/2014-AHS-Canine-Guidelines.pdf. Revised July 2014. Accessed September 28, 2016.
4 Current advice on parasite control: heartworm – canine heartworm. Companion Animal Parasite Council. https://www.capcvet.org/capc-recommendations/canine-heartworm/. Edited and revised July 2015. Accessed September 28, 2016.
5 DIROBAN™ Sterile Powder for Injection Prescribing Information. ANADA 200-609. Zoetis.