FDA Approves Clomipramine HCl Tabs to Treat Dog Separation Anxiety

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) announced October 30, 2019, that it has approved the first generic form of clomipramine hydrochloride tablets to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs older than six months of age. The drug is a generic version of the brand-name drug Clomicalm, which is manufactured by Elanco.

Statistics show that 3 out of 10 dogs surrendered to animal humane shelters are given up due to problems consistent with separation anxiety. The problem is common in dogs and results with the animal has fears or underlying anxiety about being left alone. According to the ASPCA, escape attempts by dogs with separation anxiety are often extreme and can result in self-injury and household destruction, especially around exit points like doors and windows.

Pet owners whose dogs have been prescribed clomipramine hydrochloride should be aware that it is not for use in humans. The drug should be kept out of the reach of children, and medical attention should be sought if  ingestion occurs. Clomipramine overdose in humans can cause effects such as convulsions, irregular heart rhythm and elevated heart rate. People with known hypersensitivity to clomipramine should administer the product with caution. Consult the product label for full caution information.

Clomipramine hydrochloride tablets are available by prescription only and come packaged in color-coded bottles containing 30 tablets in 5 mg, 20 mg, 40 mg and 80 mg doses. Generic clomipramine hydrochloride tablets are manufactured by Mizner Bioscience LLC, located in Boca Raton, FL.

Click here to read the full FDA announcement, including the Freedom of Information summary regarding this new animal drug application.