European manufacturer Fresnius is stepping in to help fill the US shortage in the injectible anaesthetic propofol caused by GMP problems at Teva and Hospira, that resulted in warning letters and recalls.
FDA’s lengthy warning letter to TEVA in December, posted in April, focused on the manufacture of their generic version of propofol, and primarily related to microbial contamination and testing, including endotoxin in distributed product. In July 2009, during the course of the inspection cited in the warning letter, Teva issued a recall for propofol.
A few months after the Teva warning letter Hospira also received a warning letter for propofol citing particulates in finished batches of the drug, following a November recall.
The combined propofol recalls led to a shortage in the US market, causing FDA to take the unusual step of allowing a similar drug approved in other countries, but not in the US, Fresenius’ Propoven, to be imported and sold in the US until the approved US propofol manufacturers are in a position again to supply the market.
[Editor’s Note: The June 2010 issue of International Pharmaceutical Quality will report on current focal points and trends in GMPs, inspections, and enforcement activities.]
Update May 28, 2010: Teva Pharmaceutical Industries Ltd. said today it will discontinue manufacturing its sedative propofol, but did not disclose the reason why. Teva, which is based in Israel, said it will continue marketing doses that have already been made. FDA confirmed there remains a shortage of propofol in the market.
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Announcement by FDA regarding shortages of propofol.
[Editor’s Note: The June 2010 issue of International Pharmaceutical Quality will report on current focal points and trends in GMPs, inspections, and enforcement activities.]
[Editor’s Note: The June 2010 issue of International Pharmaceutical Quality will report on current focal points and trends in GMPs, inspections, and enforcement activities.]
