Health Canada Suspends Biolyse’s Establishment License

Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems.

Health Canada confirmed on May 9 that it had suspended Biolyse’s establishment license on April 11. Regulators are, however, allowing the 6 mg/mL paclitaxel chemotherapy injections already on the market to continue being used for treatment while the drugmaker resolves the manufacturing violations.  Health Canada didn’t elaborate on the nature of the violations.

Biolyse said on Monday that none of its drug has been recalled, and emphasized that all issues have been resolved and the drugmaker is now awaiting re-inspection.

Health Canada also sought to ease any concerns about potential drug shortages as a result of its action. “There has been no supply disruption caused by the license suspension,” as the drug is available from another manufacturer, it said.

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