Serious manufacturing shortcomings at a Sanofi Pasteur plant last year created shortages of a vaccine that can protect patients against tuberculosis. Now because of manufacturing delays a drug Sanofi ($SNY) makes to treat the disease has landed on the FDA shortage list.
This time the drug is Rifamate, a pill that combines the antibiotic rifampin with isoniazid, an important treatment for TB that has been in short supply from a number of producers. Sanofi did not give a specific reason for the disruption and didn't respond to a request for comment.
Mold and contamination problems last year led Sanofi to close some operations at a plant in Toronto that previously had flooded. The disruption led to a shortage of BCG tuberculosis vaccine. An FDA warning letter last July laid out two dozen observations about the Sanofi Pasteur Toronto plant. The problems were extensive enough that the agency ordered the company to do a "comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements."
The isoniazid shortage was first reported to Centers for Disease Control and Prevention by state TB programs in November when they began having trouble getting sufficient supplies. At the time, the CDC noted that Sanofi's combination pill was still available. VersaPharm, Sandoz, and Teva Pharmaceutical Industries ($TEVA) all sell isoniazid in the U.S.
According to the FDA, isoniazid versions made by VersaPharm are still out of stock and aren't expected to return until January of next year. Sandoz has some strengths now available, though one product is still on backorder. Teva's 300-mg strengths are all available, but its 100-mg pills are on limited supply through next month. Teva has also set up an "emergency reserve" in cooperation with the FDA and CDC.
- here's the shortage notice