PRESS RELEASE: FDA Approves Diroban, the First Generic Drug to Treat Heartworm Disease in Dogs
February 17, 2017
The U.S. Food and Drug Administration today announced the approval of Diroban (melarsomine dihydrochloride), the first generic drug to treat heartworm disease in dogs.
Heartworm disease is caused by a thread-like parasitic worm called Dirofilaria immitis. The worms are called heartworms because the adult worms live in the heart, lungs, and associated blood vessels of an infected animal. In dogs, the disease results in heart failure, severe lung disease, other organ damage, and death. Heartworm disease is only spread through the bite of a mosquito; it cannot be transmitted directly from one dog to another.
Diroban is administered by deep injection into the back muscles. It is used to treat dogs with stabilized class 1 (no symptoms), class 2 (mild to moderate respiratory symptoms), and class 3 (severe respiratory symptoms) heartworm disease. It should not be used in dogs with class 4 (extremely severe respiratory symptoms) heartworm disease. Side effects of treatment may include pain, swelling, or tenderness at the injection site, coughing/gagging, decrease in activity level, lack of appetite, fever, and vomiting. Dogs should be closely monitored by a veterinarian during treatment. Following treatment, dogs should have restricted exercise for up to six weeks because active dogs are at risk for blood clots in the lungs.
Diroban must be prescribed by a licensed veterinarian because professional expertise is needed to correctly diagnose the severity of a dog’s heartworm disease and administer the drug as part of a treatment plan.
The application for Diroban is sponsored by Anzac Animal Health, LLC and distributed by Zoetis, Inc.
Read the full press release here.
Benefits of FDA Approval
As part of the approval process, the drug company must prove to FDA that:
- The drug is safe and effective for a specific use in a specific animal species;
- The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity from batch to batch; and
- The drug’s labeling is truthful, complete, and not misleading.
FDA’s role does not stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor:
- The drug’s safety and effectiveness. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
- The manufacturing process to ensure quality and consistency are maintained from batch to batch;
- The drug’s labeling to make sure the information remains truthful, complete, and not misleading; and
- The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.