FDA reinforces commitment to tackle opioid abuse with new Drug Facts Label

The US Food and Drug Administration (FDA) has created a model Drug Facts Label (DFL) to help drugmakers submit new drug applications for over-the-counter (OTD) versions of a drug that combats the effects of an opioid overdose.

It follows the launch last year, by the US Department of Health and Human Services (HHS), of comprehensive Opioid Initiative which aims to address the growing epidemic of opioid abuse in the USA.

In a monthly FDA blog, Karen Mahoney, deputy director of non-prescription drug products at the Center for Drug Evaluation and Research, says making life-saving prescription drug naloxone more accessible is vital in the efforts to reduce fatalities.