The restrictions include physician education efforts, a tracking system to determine if the drug is being used illegally and a warning label on the drug's packaging.

The caveats attached to the FDA's approval of the drug are aimed at preventing misuse of the drug and the addiction problems that were seen with OxyContin. The new drug is similar to OxyContin, but has a more potent active ingredient.

Purdue Pharma said the formulation for Palladone is different: for example, it is in capsule, not tablet, form, and has a time-release function.

The company plans to roll out Palladone in phases, and limit promotion of the drug for the first 18 months.

"The goal is to ensure safe use of the medication," said J. David Haddox, vice president for health policy at Purdue Pharma. "We're trying to optimize the benefit-risk ratio for this drug."

An FDA advisory committee recommended the restrictions after examining the potential misuse of various painkillers, including Palladone. The restrictions do not effect which doctors can prescribe the drug or which pharmacies can stock it.

Palladone will be available in the first half of next year.

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