Here’s some good news for veterinarians and pet owners who need a cheaper, generic anti-anxiety drug for dogs.
On Wednesday, the U.S. Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) has approved the first generic version of clomipramine, a drug used to treat separation anxiety, aggression, and obsessive-compulsive actions in dogs that are above six months.
To get FDA approval for generic clomipramine for dogs, the manufacturer must show that the generic version is bioequivalent to its branded version, Clomicalm, which has been found safe and effective for treating anxiety in dogs.
A study was conducted to match the bioequivalence between the generic version and the branded version. The results showed a product bioequivalence between generic clomipramine 20mg and Clomicalm 20 mg.
According to CVM, “Canine behavior problems are diagnosed in an estimated 20 to 40 percent of dogs referred to behavior practices in North America.” Most dogs reported problems with separation anxiety.
According to the American Veterinary Medical Association (AVMA), separation anxiety in dogs is one of the most common behavioral problems that is diagnosed in more than 40 percent of dogs in North America.
The AMVA said that reactions to get separated are normal in younger puppies; however, it is problematic in older dogs. Separation anxiety symptoms in dogs include inappropriate urination or defecation, aggression, and vocalization. Clomipramine is available only under a prescription. The tablets come in a color-coded bottle of 30 tablets in potencies 5 mg, 20 mg, 40 mg, or 80 mg.
