Ceva Animal Health has received U.S. approval of Cardalis, a chewable tablet formulated for the management of clinical signs of congestive heart failure in dogs due to atrioventricular valvular insufficiency.
The prescription drug is an alternative to the off-label use of human-approved products containing benazepril and spironolactone.
“Today’s approval is novel because the drugs are now approved in a combination found to be safe and effective for canine patients,” the U.S. Food and Drug Administration reported July 28.
Cardalis, once launched, is expected to be sold in three dosages pairing spironolactone and benazepril hydrochloride. The drug will be packaged in 30-count bottles.
Spironolactone is an aldosterone antagonist and benazepril hydrochloride is an angiotensin-converting enzyme (ACE) inhibitor, according to the FDA.
The agency noted that certain dog breeds have a known predisposition to atrioventricular valvular insufficiency (AVVI), including Cavalier King Charles spaniels, dachshunds, miniature and toy poodles, Chihuahuas and Yorkshire terriers.
“Although AVVI is a chronic disease, it can be medically managed with early diagnosis and a veterinarian-guided treatment plan,” the FDA stated.
Ceva Animal Health was granted approval of Cardalis across Europe in 2012.
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