Drugs

FDA Facilitating OTC Naloxone Applications

CDER Division of Nonprescription Drug Products deputy director Karen Mahoney says that FDA is taking steps to assist potential sponsors in submitting applications for an OTC form of naloxone, the prescription drug that can stop or reverse the effects of an opioid overdose. Writing in an FDA Voice blog post, Mahoney says that FDA is helping develop a package label that would be required for an OTC product. “This is an important step to help increase access to and the use of this life-saving drug,” she writes.

OTC drugs require a consumer-friendly drug facts label (DFL) that is not needed for the prescription forms of naloxone. Mahoney says that before companies submit an NDA or supplement for an OTC drug product, they develop the DFL and conduct the required studies to show that consumers can follow it to understand how to use the product without the help of a healthcare professional.

FDA has created a model DFL and an accompanying pictogram that could be placed next to the DFL to visually correspond to the label directions, Mahoney says. The model DFL and pictogram are intended to provide consumers with the information they would need to understand how to safely use naloxone, including when it is appropriate to buy the drug and how to use it in an emergency overdose situation.

FDA also has arranged for label comprehension testing of the model DFL, according to the post. Mahoney says she expects that the results of the testing that is now underway will yield important information about consumer understanding of the model naloxone DFL. Manufacturers may be able to use that information to focus their final label comprehension testing on how well consumers understand product-specific information.

“Creating a model DFL and arranging for label comprehension testing are among the ways that FDA is working to fulfill our commitment to enhanced naloxone access, where possible, in our opioids action plan,” Mahoney concludes. “We will continue to work with interested manufacturers and developers to further explore the best uses of naloxone for the emergency treatment of known or suspected opioid overdoses until emergency medical help arrives.”

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome