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Generic Versions of Oxycontin Approved

March 24, 2004|From Associated Press

WASHINGTON — The Food and Drug Administration approved the first generic versions of the controversial painkiller Oxycontin late Tuesday, a move that promises to significantly lower the drug's cost.

Oxycontin is a long-lasting version of oxycodone, a narcotic considered important therapy for many patients suffering long-term, severe pain from cancer or other illnesses. When swallowed whole, the tablet provides 12 hours of pain relief.

But if chewed, snorted or injected, Oxycontin produces a quick and potentially lethal high. It has been linked to more than 100 deaths and bears the FDA's strongest warning label, which says the drug is as potentially addictive as morphine.

While abuse of Oxycontin is a serious law enforcement problem, its cost -- hundreds of dollars a month -- has had patients who depend on its pain relief anxiously awaiting generic competition.

As part of the FDA's approval, manufacturers Teva Pharmaceuticals and Endo Pharmaceuticals may sell generic versions of extended-release oxycodone -- as long as they include abuse warnings and other steps designed to minimize illegal use that are similar to the risk-management program run by Oxycontin maker Purdue Pharma.

It's not clear how soon the generic versions could begin selling because Purdue Pharma has filed patent lawsuits.

Purdue Pharma 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, although generic competition can eventually cause drug prices to drop by a third or even half.

Generic competition promises to add to the controversy over Oxycontin because lower prices for legitimate patients can mean lower prices for drug abusers too.

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