FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs

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US Food and Drug Administration

FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs

Today, the U.S. Food and Drug Administration conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs. This is the first treatment to be approved for this condition.

“Diarrhea is a common side effect of chemotherapy in dogs, which can be so severe that cancer treatment must be halted. Chemotherapy drugs often have potential side effects, but, unlike in human medicine where patients may be willing to tolerate some discomfort in exchange for a potential cure, the primary purpose of cancer treatment in dogs and other pets is to extend survival without sacrificing quality of life and comfort,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “This new medication provides veterinarians and dog owners with another tool to help control the side effects of chemotherapy for dogs undergoing such treatment.”

Canalevia-CA1 is available only by prescription due to the professional veterinary expertise required to properly diagnosis the cause of diarrhea and monitor dogs receiving chemotherapy. Canalevia-CA1 is a tablet that is given by mouth and can be prescribed for home treatment.

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