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FDA Allows Generic Version of Scarce Cancer Drug

Tuesday Feb 5, 2013
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Federal regulators say approval of the first generic version of cancer drug Doxil will help resolve a lingering shortage triggered by manufacturing deficiencies.

The shortage of the Johnson & Johnson injectable medication, made under contract by Ben Venue Laboratories, has continued on and off for a few years. It’s resulted in rationing, with some patients with ovarian and other cancers getting less-effective care, and disrupted studies testing Doxil against possible new treatments.

The Food and Drug Administration says it’s approved a generic version, called doxorubicin, made by Sun Pharma Global FZE. Last February, the FDA authorized temporary importation from India of a brand-name version, called Lipodox, also made by Sun Pharma. It’s a subsidiary of an Indian drugmaker.

Meanwhile, J&J continues to seek a contract manufacturer to replace Ben Venue.

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