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U.S. Clears Two Generic Forms of OxyContin
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Posted by admin on Friday, March 26, 2004 - 04:45 PM
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EnviromentWASHINGTON (Reuters) - U.S. regulators approved two generic versions of the often-abused painkiller OxyContin on Tuesday after the makers agreed to take steps to prevent illegal use.
The Food and Drug Administration cleared generic forms of the prescription pain pill made by Teva Pharmaceutical Industries and Endo Pharmaceutical Holdings, an agency spokeswoman said. Privately held Purdue Pharma makes the brand-name version. "In approving these generic products, the FDA is seeking to balance the need for effective pain management therapies for the more than 10 million Americans who suffer from chronic pain with the prevention of misuse, abuse and diversion of prescription drugs," the agency said in a statement. OxyContin is used to treat moderate to severe pain from cancer and other illnesses. It is formulated to relieve pain over 12 hours, but abusers crush the pill to snort or inject it for a quick high. To prevent misuse, the generic manufacturers agreed to safeguards similar to those put in place by the brand-name maker, the FDA said. Purdue Pharma's measures have included educating prescribers, pharmacists and patients about safe use of OxyContin and surveillance of possible abuse or diversion. Generic versions of prescription drugs usually are much cheaper than their brand-name counterparts. The FDA said its research shows the arrival of generic copycats does not increase use of a drug.
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