The US Food and Drug Administration (FDA) has provided full approval of Tanovea (rabacfosadine injection) for the treatment of dogs with lymphoma. The approval was achieved under the new animal drug process, which provided a route for conditional approval for medications that treat uncommon diseases, called the Minor Use and Minor Species (MUMS) program.
"The FDA is dedicated to making treatment options available for all patients – including animals suffering from rare conditions. For example, today's first-ever full approval of a new animal drug for treating lymphoma in dogs demonstrates the positive impact that the FDA's Minor Use and Minor Species program can have on the availability of novel animal treatments," said Acting FDA Commissioner Janet Woodcock, MD. "We're committed to continuing using all our authorities to help make limited-demand treatment options available to our animal companions."
Tanovea earned conditional approval in December 2016 after the drug was deemed to offer a "reasonable expectation of effectiveness" and has since been studied in order to provide evidence for approval. Tanovea is delivered by 30-minute infusion every 3 weeks for up to 5 treatments.
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