Narcan
FDA approves over-the-counter Narcan nasal spray for opioid overdoses
The FDA on Wednesday approved 4 mg Narcan nasal spray for over-the-counter use as an emergency treatment for opioid overdose. It is the first naloxone product to be available without a prescription.
FDA committees take steps to making Narcan available over the counter
On Wednesday, two FDA advisory committees unanimously voted in favor of Narcan nasal spray being made available as an over-the-counter emergency treatment for opioid overdose.
FDA grants priority review to over-the-counter Narcan nasal spray
The FDA has accepted a supplemental new drug application for Narcan nasal spray as an over-the-counter emergency treatment for opioid overdose.
FDA approves opioid overdose antidote Zimhi
The FDA has approved Zimhi, a high-dose naloxone product that is administered through a prefilled syringe to counteract potentially fatal opioid overdoses, the agency and the drug’s manufacturer announced.
FDA issues new warnings for illegally selling kratom-based products
The FDA announced today that it issued warning letters to Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, for “illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.”