APP Pharmaceuticals expects to distribute new lots of a critically scarce leukemia drug this week, helping to ease the supply problems. But because APP is the smallest of the three cytarabine manufacturers, the shortage is likely to continue, the Wall Street Journal reports. Part of the treatment cocktail for acute myeloid leukemia, cytarabine has been so scarce that some hospitals are rationing the drug, while others have run out completely.
At the root of the shortage are manufacturing problems at two of the three cytarabine suppliers, Hospira and APP, while the third hasn't been able to keep up with demand. Hospira ran into difficulties getting the active ingredient for the drug last year. Earlier this month, it notified doctors of a production problem that had stalled shipments in February. APP had to recall one lot of the drug and stop shipping after particles were found in some cytarabine vials.
Hospira now says it has fixed its manufacturing problem and is working to ramp up production to help alleviate the shortage. It resumed shipments of the drug last month. Meanwhile, APP says it will get its version back onto the market this week. And the third manufacturer, Bedford Laboratories--which also happens to be the biggest cytarabine supplier--says it will release 82,000 vials over the next several weeks, the WSJ reports. Meanwhile, FDA says it's working on importing cytarabine to boost supplies in case the U.S. companies still can't keep up with demand.
- get the WSJ article