FDA Approves First Over-the-Counter Naloxone Nasal Spray

July and August 2024

 

The Department of Health Care Services (DHCS) releases Drug Utilization Review (DUR) articles which provide timely and relevant information on drug-specific therapy issues.

On March 29, 2023 the Food & Drug Administration (FDA) approved Narcan, the first over-the-counter naloxone 4 mg nasal spray product.

Naloxone is indicated for the emergency treatment of known or suspected opioid overdose and acts by reversing the effects of opioids. The FDA first approved naloxone nasal spray in 2015 as a prescription product.

Approval of over-the-counter naloxone increases accessibility of the life-saving medication and the drug is now available directly to consumers online or through drug stores and grocery stores. Other formulations and dosages of naloxone will remain as prescription products.

View the full FDA Approves First Over-the-Counter Naloxone Nasal Spray article.