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FDA Denies use of blue dye in an attempt to stop opioid abuse

FDA Nixes Use of Blue Dye in Opioid Painkiller

July 31, 2017
The U.S. Food and Drug Administration (FDA) voted overwhelmingly not to approve a version of Intellipharmaceutics International’s Rexista opioid that would attempt to discourage abuse by staining potential users with a blue dye that would be released upon a tamper attempt.

The FDA rejected the measure on the grounds that it would not mitigate the abuse of the drug via injection. The agency also scolded the drugmaker for not including enough information in its application about human studies that address the potential for the abuse of Rexista.

Rexista’s maker also included in the drug an irritant that would allegedly make it less attractive to those who wished to inhale it.

Rexista is a powerful opioid medication that is equivalent to OxyContin. It is intended for the treatment of severe, constant pain.

Intellipharmaceutics responded to the advisory panel’s decision by stating that it would commence further studies on the drug.

The abuse of prescription opioids kills about 30,000 Americans every year.

If you or a loved one has suffered at the hands of opioid painkillers, you may be entitled to significant financial consideration. Contact the expert attorneys at to learn how we can help you.

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