Amneal Pharmaceuticals, Inc. announced the availability of Over the Counter (“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following Abbreviated New Drug Application (“ANDA”) approval from the FDA. Amneal’s Naloxone HCI Nasal Spray, manufactured in the U.S., is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication that is widely used to help treat drug overdose from opioids, including heroin, fentanyl and prescription opioid medications.
“With today’s launch, Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription. Our business is deeply rooted in a commitment to helping others. By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands of even more people who could potentially save countless families and communities from further heartache and loss,” said Chirag and Chintu Patel, Co-Chief Executive Officers.
More than two-thirds of all drug overdose fatalities in 2022 involved illicit, synthetic opioids like fentanyl, which is the culprit in more deaths under age 50 than any other cause, including heart disease, cancer, homicide, suicide, and other accidents. According to the Centers for Disease Control and Prevention, in about 46% of overdose deaths, another person is present and has the potential to intervene.
Amneal Naloxone HCI Nasal Spray is now available. According to IQVIA®, U.S. annual commercial sales for NARCAN® Naloxone HCl Nasal Spray 4mg for the 12 months ended February 2024 were $266 million. In addition, there are significant volumes of the product acquired directly by U.S. states and municipalities. NARCAN® is a registered trademark of Emergent Operations Ireland Limited.
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