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FDA approves generic cancer drug

2/4/2013

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic version of a cancer drug in a move that the agency said would help relieve shortages.


The FDA announced the approval of Sun Pharma Global's doxorubicin hydrochloride liposome injection, a generic version of Johnson & Johnson's Doxil. The drug is currently on the agency's list of drugs experiencing shortages.


"The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them," FDA director of drug shortage staff Valerie Jensen said. "For the past year, the FDA has been working to ensure that supplies of doxorubicin hydrochloride liposome injection were not interrupted."


In February 2012, the agency allowed temporary, controlled importation of a version of the drug made abroad.




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