April 01, 2017

 

 Generic heartworm treatment approved

Posted March 15, 2017

A generic heartworm disease treatment gained federal approval in February during a shortage of the brand-name equivalent. 

The antiparasitic, Diroban, is a melarsomine dihydrochloride product and the first generic heartworm treatment to receive Food and Drug Administration approval. The name-brand version, Immiticide, was unavailable because of a manufacturing shortage, FDA information states.

Diroban is sponsored by Anzac Animal Health and distributed by Zoetis. Immiticide, when available, is sold by Merial.

The injectible drug can be used to treat dogs with stabilized class 1 through 3 heartworm diseases, which range from dogs without clinical signs to dogs with severe respiratory problems.

A Feb. 17 FDA letter to veterinarians indicates agency officials recommend that veterinarians administer Diroban while Merial works to address the Immiticide shortage. The letter also includes reminders that generic and brand-name drugs need to have the same quality, performance, and intended uses as well as bioequivalence.

The letter to veterinarians is available here.