On Friday, the Food and Drug Administration (FDA) gave Israeli drugmaker Teva Pharmaceuticals Inc. final approval to market its generic naloxone spray, offering a less-costly alternative to the life-saving medication that can stop or reverse the effects of an opioid overdose.
He said the agency is also looking into prescribing naloxone alongside any opioid that poses the danger of a fatal overdose.
To combat the problem of increasing death rate in the United States due to opioid overdose, the FDA has approved a generic variant of naloxone.
Everyone from the US Surgeon General to Demi Lovato - who credits Naloxone with saving her from an overdose - is urging more Americans to buy and carry the drug, and be prepared to save a life.
The Centers for Disease Control and Prevention (CDC) has reported that almost 400,000 people in the US died from an opioid overdose from 1999 to 2017. However, it is important to note that it is not a substitute for immediate medical care, and the person administering naloxone nasal spray should seek further immediate medical attention on the patient's behalf.
Naloxone has been sold as a nasal spray in the USA since 2016 under the brand name Narcan. It announced plans to expand availability of naloxone at the beginning of the year. As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency communication with sponsors; and expanded agency engagement similar to Generic Drug User Fee Act enhancements for complex products, such as pre-submission and midcycle meetings.
This is the first generic version of nasal spray naloxone, but generic forms of injected naloxone are already available for use in healthcare settings, according to a media release from the FDA.
Growing awareness in the USA of the risks associated with opioid over-prescription and overuse has led to a backlash against industry practices carried out by drugmakers. The medication will come in the form of a nasal spray and it will be easily administered by anyone to help a patient who has overdosed. It does not require assembly and delivers a consistent, measured dose when used as directed.
Teva, the world's largest manufacturer of generic drugs, is one of the companies named in lawsuits by the State of Oklahoma, the City of Seattle, and other class action suits over its role in the opioid crisis.