February 9, 2017, FDA.gov
The U.S. Food and Drug Administration is giving notice that the agency is withdrawing the conditional approval for Paccal Vet-CA1 (paclitaxel for injection) at the request of the drug’s manufacturer, Oasmia Pharmaceutical AB. Paccal Vet-CA1 was intended to treat certain mammary and squamous cell carcinomas in dogs that have not received previous chemotherapy or radiation therapy. The conditional approval for Paccal Vet-CA1 is no longer in effect as of February 8, 2017. Paccal Vet-CA1 is now an unapproved animal drug with no legal marketing status and further sales of the drug are illegal.
Oasmia Pharmaceutical AB must stop marketing and distributors must stop distributing the drug to veterinary clinics. Veterinarians should stop using Paccal Vet-CA1, and pet owners whose dogs are on the drug should discuss other treatments with their veterinarians.
Only animal drugs intended for minor species, such as ferrets or fish, or for minor uses in a major species, such as to treat certain types of cancer in dogs, may be eligible for conditional approval. 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 proposed conditionally-approved use. Conditional approval allows the drug company to legally market the animal drug for up to five years. During this period, the company develops and submits to the FDA—and the agency reviews—the necessary data to prove that the drug meets the “substantial evidence” standard of effectiveness for full approval.