The U.S. Food and Drug Administration has given conditional approval to Ishihara Sangyo Kaisha Ltd for Panoquell-CA1 (fuzapladib sodium for injection) for acute onset of pancreatitis while the dog is hospitalized for treatment of the disease.
Fuzapladib sodium, the active ingredient in Panoquell, has been used in Japan since 2018 and FDA reviewed data from there as part of its assessment of the application for conditional approval.
Conditional approval means that the drug is safe and has a reasonable expectation of effectiveness.
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.
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