FDA Acts To Stem Shortages Of Cancer Drugs Doxil And Methotrexate

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DOXIL METHOTREXATE
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Feb 21 (Reuters) - The Food and Drug Administration is addressing the U.S. shortage of critical cancer medications by importing one drug from abroad and rushing the approval of another.

The move announced on Tuesday is the latest government effort to stem the shortages of drugs in the United States, which doctors and patient advocates say have forced providers to postpone care or use second-best or costlier alternatives.

The FDA said it would allow cancer drug Doxil to get shipped from abroad and also approve a new manufacturer of methotrexate, a drug used to treat childhood leukemia.

Doxil, a cancer drug from Johnson & Johnson, has been in persistent short supply since manufacturing problems surfaced at a plant of Ben Venue, a unit of German drugmaker Boehringer Ingelheim.

The injectable drug, which has annual global sales of about $500 million, is used to treat ovarian cancer and multiple myeloma.

The plant's problems have also contributed to a shortage of methotrexate, leading U.S. lawmakers to call for action last week from the FDA and the manufacturers.

President Barack Obama made shortages a national priority with an executive order in October, and the FDA has prevented 114 shortages since then by working with manufacturers.

The FDA has said the number of drugs in short supply had risen to 220 in 2011 from 56 in 2006 -- the year a clear trend started emerging.

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