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FDA News Release
Today, the U.S. Food and Drug Administration conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of pancreatitis in dogs. Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment of the disease.
Pancreatitis is a painful inflammatory disease of the pancreas that can be life-threatening and generally requires that dogs be hospitalized for treatment. In most cases, it occurs spontaneously. Common factors that increase the chance of developing pancreatitis include when dogs eat something outside of their normal diet (particularly fatty foods), treatment with certain medications, and diseases like diabetes mellitus. It is more common in certain breeds of dogs and in some dogs may become a recurring or chronic condition.
“This is the first drug to address a serious and life-threatening disease that previously could only be managed through supportive care, such as intravenous fluids, pain medication, anti-emetics, and dietary rest,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “The conditional approval pathway allows medications like Panoquell-CA1 to reach the marketplace more quickly, and in this case gives dogs suffering from acute onset of pancreatitis earlier access to a drug to manage this disease.”
Conditional approval also means that, when used according to the label, the drug is safe and has a reasonable expectation of effectiveness. Veterinarian access to critical animal drugs provides more options for treating animals with uncommon conditions, serious or life-threatening diseases, or diseases without existing or adequate therapies. The initial conditional approval is valid for one year with the potential for four annual renewals. During this time, the animal drug sponsor must demonstrate active progress toward proving substantial evidence of effectiveness for full approval. If the sponsor does not meet the requirements for substantial evidence of effectiveness at the conclusion of five years, the product can no longer be marketed.
Fuzapladib sodium, the active ingredient in Panoquell, has been approved since 2018 in Japan to improve clinical signs in the acute phase of pancreatitis in dogs, but not in the United States until today. The FDA reviewed data associated with fuzapladib’s use in Japan as part of its assessment of the application for conditional approval.
Veterinarians should advise owners about the possible side effects, which include loss of appetite, digestive tract disorders, respiratory tract disorders, liver disease and jaundice, before using the drug. The FDA encourages dog owners to work with their veterinarian to report any adverse events or side effects potentially related to the use of any drug, including Panoquell-CA1.
The FDA granted conditional approval of Panoquell-CA1 to Ishihara Sangyo Kaisha Ltd.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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