FDA Approves Generic Naloxone Nasal Spray

The FDA has approved the first generic of naloxone hydrochloride nasal spray for the treatment of opioid overdose. The new option is intended for use by individuals without medical training.

Previously, the FDA has approved brand-name naloxone nasal spray and an auto-injector for use by individuals without medical training.

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The nasal spray does not require assembly and delivers a measured dose of naloxone. It can be used in either children or adults.

Use in individuals who are opioid dependent could result in severe opioid withdrawal, which may include symptoms of body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

—Michael Potts

Reference:

FDA approves first generic naloxone nasal spray to treat opioid overdose [press release]. April 19, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636333.htm.