Sanofi Pasteur's Toronto plant can release one lot of its bladder cancer treatment for sale, Canadian regulators said. The drug, ImmuCyst, had been on hold because of problems flagged at the plant, which is now idled for an overhaul.
It's just the latest example of production problems touching off drug-supply woes. At a time when a record number of drugs are running short, drugmakers have been idling plants--even shutting them down--to make changes necessary to satisfy FDA and other regulators.
Health Canada said one lot of 1,500 ImmuCyst doses could be sold, after expert review found no direct evidence that the drug was contaminated with mold found at the plant earlier this year, the Canadian Press reports. The agency also said it has received no reports that ImmuCyst patients suffered infections caused by contaminated treatments.
The mold contamination already triggered a shortage of the tuberculosis vaccine BCG. Sanofi recalled four batches of the vaccine in June on sterility worries, and the company halted production at the Canadian plant soon after. Officials had feared that ImmuCyst would run short as well. With production still on hiatus as Sanofi cleans up its act, there's no guarantee that it won't.
- read the Canadian Press story