AB Science must cease marketing Kinavet-CA1 and distributors must stop distributing the drug to veterinary clinics after the FDA pulled the drug's conditional approval.
The drug used to treat mast cell tumors in dogs is no longer approved, as of Dec. 15, 2015, according to the FDA. It is now considered an unapproved animal drug with no legal marketing status, and further sales of the drug are illegal.
To receive a conditional approval, a drug company must prove, among other things, that the animal drug is safe and has a “reasonable expectation of effectiveness” when used according to the label for the conditionally-approved use. Conditional approval allows the drug company to legally sell the animal drug for up to five years.
It was not immediately clear why the agency pulled the conditional approval.