News Release Details
News Release Details
Jaguar Animal Health Sponsors October 26th Episode of dvm360 Live! to Drive Awareness of Canalevia-CA1 and Participation in Jaguar’s Take C.H.A.R.G.E. (Canine Health And ReGistry Exchange) Initiative
Canalevia®-CA1, which received conditional approval from the FDA on
Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Due to the increasing number of chemotherapeutic agents being adopted by veterinarians and veterinary oncologists, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,1 and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the
"We established Take C.H.A.R.G.E. to fill a major research gap among the veterinary community and dog owners in
dvm360 Live! features in-depth clinical discussions with leaders in veterinary medicine, trending veterinary news, and inspiring veterinary stories and interviews.
dvm360® has been a leading multi-media provider of animal health care communications, education, and research for veterinary professionals for over 50 years.
Crofelemer is a novel, oral plant-based medicine extracted and purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest.
Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is an oral formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is conditionally approved by the FDA under application number 141-552. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for a full approval. Jaguar has received Minor Use in a Major Species (MUMS) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a "small number" threshold for minor use in each of the seven major species covered by the MUMS act. The small number threshold is currently 70,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use.
Important Safety Information About Canalevia-CA1
For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.
For more information about
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that information from Take C.H.A.R.G.E. will provide the first ever national representation of the incidence and prevalence of canine cancer and will help inform decisions that advance the quality of life of both dogs with cancer and their owners, and Jaguar's expectation that data from Take C.H.A.R.G.E. may also provide insights to help better understand cancer in humans. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the
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