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Generic Oxycontin soon available


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WASHINGTON (AP) -- The first generic versions of the potent painkiller OxyContin have been approved for market, a move likely to help patients with long-term pain save money on the drug that has been illegally used by drug abusers.

OxyContin is a long-lasting version of oxycodone, a narcotic considered important therapy for many patients suffering long-term, severe pain from illnesses such as cancer. The tablet, when swallowed whole, provides 12 hours of pain relief.

Late Tuesday, the Food and Drug Administration cleared Teva Pharmaceuticals and Endo Pharmaceuticals to sell generic versions of extended-release oxycodone. As a condition, the companies must include abuse warnings, doctor education and other steps aimed at minimizing illegal use that are similar to the risk-management program run by OxyContin maker, Purdue Pharma.

It's unclear when the generic versions will go on the shelves. A federal judge recently ruled some OxyContin patents unenforceable, clearing the way for generic competition, but Purdue Pharma has filed legal notice that it will appeal.

Purdue Pharma also had petitioned the FDA to block generic approval unless its competitors used an identical risk-management program. But the FDA on Tuesday decided that the generic companies' plans were similar enough.

Teva and Endo haven't said how much they will charge, but generic competition can eventually cause drug prices to drop by a third or even half.

The availability of the generic versions likely will complicate the controversy over OxyContin because lower prices for legitimate patients can mean lower prices for drug abusers, too.

The FDA, however, is bound by law to approve generic competition of effective drugs. Agency officials said in a statement they were seeking to balance effective pain management for more than 10 million Americans who suffer chronic pain with a minimized potential for abuse.


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