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Canine cancer drug loses conditional FDA approval


The drug Paccal Vet-CA1to treat mammary and squamous cell carcinomaswas withdrawn at the manufacturer's request.

The U.S. Food and Drug Administration (FDA) is withdrawing its conditional approval of Paccal Vet-CA1 (paclitaxel for injection) at the request of Oasmia Pharmaceutical AB, the drug's manufacturer, according to an agency release. The drug was intended to treat certain mammary and squamous cell carcinomas in dogs that had not received previous chemotherapy or radiation therapy.

What's conditional approval?

Conditional approval is given to 1) animal drugs intended for minor species, such as ferrets or fish, or 2) drugs for minor uses in a major species, such as to treat certain types of cancer in dogs, the FDA states. To qualify, 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. Conditional approval allows the drug company to legally market the animal drug for up to five years. During the time of conditional approval the company submits the necessary data to the FDA to prove that the drug meets the "substantial evidence" standard of effectiveness for full approval.

As of Feb. 8, 2017, the conditional approval is no longer in effect and the drug is now an unapproved animal drug with no legal marketing status. Further sales of the drug are illegal, the release states. Oasmia Pharmaceutical AB must stop marketing the drug, distributors must stop distribution, and veterinarians should stop using it on patients. Pet owners whose dogs are on the drug should discuss other treatment options with their veterinarians.

Oasmia Pharmaceutical AB received conditional approval for Paccal Vet-CA1 (paclitaxel for injection) in February 2014.

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