Canine cancer drug loses conditional FDA approval

Canine cancer drug loses conditional FDA approval

The drug Paccal Vet-CA1—to treat mammary and squamous cell carcinomas—was withdrawn at the manufacturer's request.
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Feb 13, 2017
By dvm360.com staff

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.

As of Feb. 8, 2017, the conditional approval is no longer in effect and the drug is now an unapproved animal drug with no legal marketing status.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.