February 17, 2017
The U.S. Food and Drug Administration (FDA) recently approved the antiparasitic drug DIROBAN, a generic melarsomine dihydrochloride product for treating heartworm disease in dogs (Abbreviated New Animal Drug Application 200-609). IMMITICIDE, the brand-name drug marketed by Merial, Inc., is not currently available in the U.S. due to a manufacturing shortage. DIROBAN is currently the only FDA-approved drug available in the U.S. to treat canine heartworm disease. FDA wants to remind you of the benefits of using FDA-approved drugs in your clinic.
Sponsored by Anzac Animal Health, LLC and distributed by Zoetis, Inc., DIROBAN is a prescription animal drug supplied as a sterile powder that must be reconstituted with an accompanying sterile water diluent. The drug is intended to treat stabilized Class 1, 2, and 3 heartworm disease caused by immature (4-month-old, stage L5) to mature adult infections of Dirofilaria immitis. Please refer to the Freedom of Information Summary and package insert for DIROBAN before using it.
DIROBAN is the first FDA-approved generic melarsomine product. FDA requires a generic drug to have the same quality, performance, and intended uses as the approved brand-name drug. The generic drug must also be bioequivalent to the brand-name drug. DIROBAN has met these criteria and is considered equivalent to IMMITICIDE.
Benefits of FDA Approval
FDA rigorously evaluates an animal drug before approving it. 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.
FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe and effective drugs are available for animals. For more information, please contact CVM’s Education & Outreach Staff at 240-402-7002 or AskCVM@fda.hhs.gov.
FDA’s Center for Veterinary Medicine