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APRIL 26, 2024

FDA Approves New OTC Naloxone Nasal Spray for Emergency Use

The FDA has approved over-the-counter (OTC) naloxone hydrochloride (HCI) nasal spray, USP, 4 mg (Amneal  Pharmaceuticals), following an abbreviated new drug application review.  Naloxone HCI Nasal Spray is a generic equivalent to OTC Narcan HCI Nasal Spray (Emergent), a medication that is widely used to help treat drug overdose from opioids, including heroin, fentanyl and prescription opioid medications.

Naloxone HCI Nasal Spray is designed to rapidly reverse the effects of a