FDA Okays Generic Nasal Spray To Treat Opioid Overdose

FDA Okays Generic Nasal Spray To Treat Opioid Overdose

Introduction

On Friday, April 19, the Food and Drug Administration (FDA) granted final approval to the first generic version of naloxone hydrochloride nasal spray, also known as Narcan, to treat opioid overdoses.

The newly-approved spray is a Teva Pharmaceuticals product and had received tentative approval by the FDA in June 2018. Generic injectable naloxone products were available in the market for years; however, this was the first time a generic naloxone nasal spray was approved for use in a community where individuals using them to treat overdose, do not require any medical training. The drug can be sprayed into one nostril while the patient is lying on his or her back, and can be repeated if necessary. The agency also plans to take additional measures, to review new generic drug applications for treating opioid overdose, and to come up with a plan of action to help facilitate an over-the-counter naloxone product.

As per reports by the Centers for Disease Control and Prevention (CDC), almost 400,000 people died owing to opioid addiction and overdose between 1999 and 2017.