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  1. CVM Updates

FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats

May 14, 2018

The U.S. Food and Drug Administration has approved Mirataz (mirtazapine transdermal ointment), a new animal drug to manage undesired weight loss in cats. Mirataz is the first transdermal product to receive FDA approval for use in cats. FDA-approved drugs have been demonstrated to be safe and effective for their intended use.

Weight loss is often the first indication of chronic disease in cats. For example, cats with kidney, gastrointestinal, or dental disease often exhibit weight loss. Although the goal of treatment should be to manage or cure the underlying disease, medical intervention may be needed to try to stop or slow accompanying weight loss.

The FDA is aware that there are also transdermal formulations of mirtazapine compounded from bulk drug substances available through many compounding pharmacies. With today’s approval, veterinarians now have an approved mirtazapine product with known safety, efficacy, and quality to provide to their patients rather than having to rely on products compounded from bulk drug substances that are unapproved animal drugs.

Mirataz is administered transdermally by applying a ribbon of ointment over the inner surface of the cat’s ear using a gloved finger. Because the drug is administered transdermally, gloves should be worn when handling Mirataz to prevent accidental topical exposure to humans. After application, people should dispose of used gloves and wash hands with soap and water. Appropriate safety measures should be taken so that people or other animals in the household do not come in contact with the treated cat for at least two hours.

Mirataz must be prescribed by a licensed veterinarian because a trained professional is needed to correctly diagnose the cause of weight loss in cats and determine whether Mirataz is an appropriate treatment.

Mirataz is manufactured by Kindred Biosciences, Inc.

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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