Generic 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.

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.