Conditional Approval granted by FDA for PANOQUELL®-CA1, the first drug in the U.S. to manage Acute Onset of Pancreatitis in Dogs
ISK Healthcare Business Headquarters’ new product, Panoquell-CA1 (fuzapladib sodium for injection) was conditionally approved on November14 by the U.S. Food and Drug Administration (FDA), as the first drug in the U.S. for the management of clinical signs associated with acute onset of pancreatitis in dogs.
Fuzapladib sodium, the active ingredient in Panoquell-CA1, has been approved since 2018 in Japan to improve clinical signs in the acute phase of pancreatitis in dogs, and has been marketed under the name of “BRENDA®” for use by veterinarians in Japan. With this conditional approval in the U.S., ISK plans to market it overseas for the first time.
Conditional approval 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 through conditional approval provides options for treating animals with uncommon conditions, serious or life-threatening diseases, or diseases without existing or adequate therapies.
Marketing and distribution of this drug in the U.S. will be carried out by Ceva Animal Health, LLC, Lenexa, Kansas, USA. The company is an affiliate of Ceva Santé Animale S.A., a leading French animal health company.
The ISK pipeline has multiple veterinary drug development programs that are progressing toward commercialization. Panoquell-CA1 will be the first product to be launched in the global market for veterinary medicine.
In ISK’s Vision2030, veterinary drugs and related products are targeted to achieve sales of 15 to 20 billion yen in fiscal 2030 and to develop the product line into our third major industrial category.
(US) ISK Animal Health, LLC
(Japan) Ishihara Sangyo Kaisha, Ltd.