May 9, 2019

FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose

The FDA has approved the first generic naloxone hydrochloride nasal spray, commonly know by its brand name Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose, including potentially fatal respiratory depression, and which can be used by individuals without medical training.

While generic naloxone products have been available for years for use in healthcare settings, this is the first generic naloxone product that can be used by members of the public, as this product does not require assembly and delivers a consistent, measured dose when used as directed.

Use of naloxone nasal spray in patients who are opioid-dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

The FDA is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.

For more information, read the FDA News Release.

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