Health Care Industry
Industry: Email Alert RSS FeedGeneric oxycodone gets cautious nod
Drug Store News, April 5, 2004
WASHINGTON -- In a major development on the generic drug front, the Food and Drug Administration approved Endo Pharmaceutical's and Teva Pharmaceutical's versions of Purdue Frederick's OxyContin (oxycodone extended-release tablets) for the management of moderate-to-severe pain. But the green light came with a powerful warning.
The FDA's approval came with a set of guidelines to generic drug makers that require they put a risk management plan into place before marketing me-too versions of the powerful opioid, which is known for its potential for abuse, misuse and diversion.
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On March 24, Endo was granted final approval for its abbreviated new drug application and 180 days of marketing exclusivity for oxycodone extended-release tablets in 10 mg, 20 mg and 40 mg strengths. On the same date, Teva was awarded 180-day exclusivity for its 80 mg strength version of the painkiller.
OxyContin had combined U.S. sales of $1.9 billion in 2003.
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