APP, Hospira resolve shortage of cytarabine

One of the many cancer drug shortages--of cytarabine, a treatment for acute myeloid leukemia--has been resolved.

Drugmakers APP Pharmaceuticals ($APPX) and Hospira ($HSP) report "good supply" and they anticipate no further problems, according to the FDA's drug shortages listing. Bedford Labs is working to increase supplies as well.

Cytarabine has been in short supply for about a year, reports Dow Jones. But production problems leading to the shortage at Hospira and APP, a unit of Fresenius SE ($APCVZ), are now "fully resolved."

Among the production issues leading to the shortage was particle contamination, which turned out to be clumps of dried API, the news service says. The clumps dissolved when the vials were warmed, however, and because of the shortage, the FDA permitted some to be shipped with instructions for use.

Hospira had also cited a lack of a API as contributing factor. Bedford Labs was unable to compensate for the supply deficit of its competitors.

APP resolved its cytarabine shortage by "significantly increasing production" at its U.S. manufacturing facilities, according to a statement from spokeswoman Debra Lynn Ross, via email. The generics-maker last week announced it had resolved its propofol shortage by enlisting production capacity from Fresenius sites in Europe.

"Although sudden demand fluctuations and active pharmaceutical ingredient shortages are outside of APP's control, the company has put in place several preventative measures," the statement says.  Included in these measures is building higher levels of inventory for APIs with long lead times. The company also undertakes frequent reviews with the FDA's Drug Shortage program, and it's increasing manufacturing capacity through facilities investments.

- see the story
- here's the FDA listing

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