FDA APPROVED: OTC Naloxone

In life-saving news, the FDA has approved, for the first time, over the counter use of Narcan, 4 mg naloxone hydrochloride nasal spray. By increasing ease of access by selling directly to consumers whether online or via grocery stores, gas stations, drug stores, or convenience shops, the FDA hopes to reduce the more than 100,000 yearly fatal overdoses causes by illicit fentanyl and other synthetic opioids.

FDA Commissioner Robert M. Califf, MD, stated, “the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need. Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

 

Read the FDA press release here.

Other Categories:

• guidelines

• naloxone

• opioids