October 30, 2019
The U.S. Food and Drug Administration’s Center for Veterinary Medicine is announcing the approval of 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 greater than 6 months of age.
Separation anxiety is common in dogs and results when a dog fears or has underlying anxiety about being left alone. It has been published that separation anxiety behavior problems are diagnosed in an estimated 20 to 40 percent of dogs that are referred to behavior practices in North America. In a survey of factors associated with surrendering dogs to a humane society, 3 out of 10 of the most commonly reported problems were consistent with separation anxiety.
The sponsor of an abbreviated new animal drug application (ANADA) for a generic animal drug is required to show that the generic product is bioequivalent to the reference listed new animal drug (in this case, Clomicalm), which has been shown to be safe and effective. Bioequivalence means that the bioavailability of a generic new animal drug and the referenced listed new animal drug (RLNAD) must be the same, meaning that the extent and rate of absorption of the active pharmaceutical ingredient(s) (API) or its metabolite(s) are equal, therefore behaving and acting in the same manner as Clomicalm tablets. For this ANADA, one in vivo blood-level study was conducted, which demonstrated product bioequivalence between the generic 20 mg clomipramine hydrochloride tablet and the 20 mg Clomicalm (clomipramine hydrochloride) tablet. Additional dissolution studies were performed to grant a waiver from the requirement to demonstrate in vivo bioequivalence for the 5 mg, 40 mg, and 80 mg tablet strengths.
Pet owners whose dogs have been prescribed clomipramine hydrochloride should be aware that it is not for use in humans, and they should keep the product out of reach of children, and seek medical care 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.
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For questions, Contact CVM.