FDA Prioritizes Generic Opioid Overdose Treatments

The FDA announced that it will give priority reviews to ANDAs for opioid overdose treatments to help address the ongoing public health emergency.

The agency says it will pay special attention to ANDAs that reference the following NDAs for drugs indicated for the emergency treatment of known or suspected opioid overdoses:

• Adapt Pharma’s Narcan (naloxone hydrochloride) injection, NDA 016636;
• Adapt Pharma’s Narcan (naloxone hydrochloride) nasal spray, NDA 208411;
• Kaléo’s Evzio (naloxone hydrochloride) auto-injectors, NDAs 205787 and 209862; and
• Eurohealth International’s Revex (nalmefene hydrochloride) injection, NDA 020459.

These reference listed drugs are “critical medications for saving the lives of individuals impacted by the ongoing opioid crisis,” CDER said.

Note: Story updated 7.17.19