FDA approves generic melarsomine product for heartworm treatment

FDA approves generic melarsomine product for heartworm treatment

Zoetis releases Diroban (melarsomine dihydrochloride) injection amid long-term shortage issues.
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Feb 24, 2017
By dvm360.com staff

The U.S. Food and Drug Administration (FDA) has approved Diroban, a generic melarsomine dihydrochloride antiparasitic drug for treating heartworm disease in dogs, according to an agency release. The drug is sponsored by Anzac Animal Health and distributed by Zoetis.

Immiticide, the brand-name drug marketed by Merial, has experienced a manufacturing shortage since early 2010 and is not available in the United States, though the FDA has allowed Merial to import its EU-approved product to help fill the need for heartworm disease treatment. That program is still in effect, says Lindsay Dashefsky, MPH, FDA health communications specialist, in an email to dvm360.

With this approval, Diroban becomes the only FDA-approved drug available in the U.S. to treat canine heartworm disease, according to the agency release. It is a sterile powder that must be reconstituted with an accompanying sterile water diluent. It is intended for treatment of stabilized class 1, 2 and 3 disease caused by immature to mature adult infections of Dirofilaria immitis.

The drug is also the first FDA-approved generic melarsomine product. The agency requires generic drugs to have the same quality, performance and intended uses as the approved brand name drug. Diroban is identical to Immiticide in active ingredient, strength, dosage form and dosage regimen, the agency states. It is also bioequivalent to Immiticide. While Merial continues to address its shortage, the agency recommends veterinarians use Diroban to treat dogs with heartworm disease.