Generic Oxycodone Gets FDA Approval March 31, 2004
News Summary
The Food and Drug Administration's (FDA's) approval of two generic versions of the painkiller oxycodone is expected to significantly lower the cost of the controversial drug -- not only for legitimate patients but individuals who obtain it illegally, the Associated Press reported March 24.The FDA approved extended-release versions of oxycodone -- the active ingredient in Oxycontin -- from manufacturers Teva Pharmaceuticals and Endo Pharmaceuticals.
The approval requires the companies to include misuse warnings on the packaging and to implement measures to minimize illegal use.
Purdue Pharma, the maker of Oxycontin, has filed patent lawsuits, so a release date for the generic versions has not been set.
The generic drugs fuel the controversy about the misuse of Oxycontin by people who chew, snort, or inject the tablets to achieve a quick and potentially deadly high. But FDA officials said they are required by law to approve generic versions from competitors of effective drugs.
COMMENTS ON THIS ARTICLE: