TRENTON, N.J. (AP) — Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have patients worried about missing life-saving treatments.
The Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn't been available for new patients for months.
The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug high doses.
The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories and its complex in Bedford, Ohio, possibly for a year, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.
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