Just approved: Generic clomipramine for canine separation anxiety

The tricyclic antidepressant Clomicalm (clomipramine hydrochloride, Elanco) was approved just over 20 years ago for veterinary use. Today, the FDA announced on its website that a generic version of clomipramine has been approved by the Center for Veterinary Medicine.

Clomipramine, used in veterinary medicine as part of a comprehensive behavioral management program to treat separation anxiety in dogs over 6 months of age, reduces the clinical signs of separation anxiety by increasing brain serotonin levels to balance out mood.

Although exact prevalence data are unavailable, experts indicate that separation anxiety affects an estimated 20% to 40% of dogs that present to veterinary behavior specialists.

To gain FDA approval, the manufacturer, Mizner Bioscience, LLC, located in Boca Raton, Fla., submitted an abbreviated new animal drug application that showed via an in vivo blood-level study that the 20-mg tablet of its generic version of clomipramine is bioequivalent to the 20-mg tablet of Clomicalm. Based on data from dissolution studies, a biowaiver was granted for the 5-, 40- and 80-mg generic tablets.

dvm360 spoke with Amy L. Pike, DVM, DACVB, owner of the Animal Behavior Wellness Center in northern and central Virginia, to get her take on this announcement. Although the availability of a generic will benefit clients financially-Clomicalm can be expensive, especially for large-breed dogs, she said-one concern with all generic medication is that the manufacturer is not required to prove safety or efficacy, only that the drug contains the active ingredient.

"With psychotropic medication, we often find that response to brand can be different than response to generic," Dr. Pike said. "Many human psychiatrists find this to be true for their patients as well."

The recommended daily dose of clomipramine (administered once or twice daily) is 2 to 4 mg/kg (0.9–1.8 mg/lb). Available by prescription only, clomipramine is packaged in color-coded bottles containing 30 tablets in 5-, 20-, 40- and 80-mg doses.