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FDA rejects application of pain-relief drug


PALATINE, Ill. The Food and Drug Administration has rejected an approval application for a pain-relief drug.

Acura Pharmaceuticals and King Pharmaceuticals announced that the FDA had issued a letter turning down their application for Acurox (oxycodone HC1, USP and niacin, USP), an immediate-release drug designed to relieve moderate to severe pain.

The companies said the letter expressed concerns about the potential abuse deterrent benefits of the drug. One of the drug’s ingredients, oxycodone, is a opiate-derived controlled substance popular with drug abusers.

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