A bladder cancer drug that has been in short supply after FDA inspectors cited a Sanofi ($SNY) plant in Canada for mold problems will be available again in the second half of next year.
Drug distributor Alliance Pharma announced today as part of a financial update that it expects to have ImmuCyst in supply in the second half of 2014.
Availability of ImmuCyst and Sanofi's BCG tuberculosis vaccine were affected last year when the company shut down operations at a vaccine plant in Toronto, Canada. An FDA warning letter laid out two dozen observations, detailing mold and contamination issues. Among other problems at the Toronto plant, the FDA says, "there have been no less than 58 documented non-conformances relating to the isolation of mold within the BCG aseptic processing areas" since August 2010.
Health Canada said in September that it was releasing one lot of 1,500 ImmuCyst doses that Sanofi had on hand, saying an expert review found no direct evidence that the drug was contaminated with the mold. The agency also said it has received no reports that ImmuCyst patients suffered infections caused by contaminated treatments.
- here's the Alliance Pharma press release