FDA allows generic of scarce cancer drug

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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Bet Johnson & Johnson is hoppin' mad over this one. I'm sure they wanted to control supply and demand forever. It's hellacious what big pharma and the American Cancer Society does to keep cancer treatment expensive and not necessarily successful.

Right now I have a friend with pancreatic cancer http://tinyurl.com/d7jr4f6 He's beating the odds and has lived 18 months - far longer than he was told he would live - but it's been h*ll on his body. He says it's hard to tell what's worse - the ain from cancer or the pain from chemo.

    Reply#1 - Fri Mar 1, 2013 4:09 AM EST
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