FDA gives final approval for first generic nasal spray to treat opioid overdose

FDA gives final approval for first generic nasal spray to treat opioid overdose
Naloxone hydrochloride

(WAFB) - The FDA announced Friday it has approved the first generic nasal spray meant to treat opioid overdoses.

The final approval of naloxone hydrochloride nasal spray, also known as Narcan, is a medication that can stop or reverse the effects of overdoses.

In addition, the FDA is planning steps to prioritize the review of additional generic drug applications for similar products. The agency will also help facilitate an over-the-counter naloxone product.

While the generic injectable naloxone products have been available for years to use in a healthcare setting, the generic nasal spray can be used without medical training. Naloxone nasal spray does not require assembly. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training. The agency says it hopes the approval will make the medication more accessible to the public. The FDA approved the generic drug product on June 8, 2018. Teva Pharmaceuticals USA Inc. has received final FDA approval to market generic naloxone nasal spray.

According to the Centers for Disease Control and Prevention, almost 400,000 people died from an opioid overdose from 1999 to 2017. On average, more than 130 Americans die every day from opioid overdoses.

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