Amneal begins supplying OTC naloxone hydrochloride nasal spray to California

Amneal has begun supplying its over-the-counter naloxone hydrochloride (naloxone HCI) nasal spray, 4 mg to U.S. retail pharmacies and the state of California. The product is now available for direct distribution to states and municipalities across the U.S.

The Food and Drug Administration approved Amneal’s naloxone HCI nasal spray in April 2024. Amneal’s naloxone HCI nasal spray is a generic to OTC NARCAN HCI Nasal Spray, a medication widely used to help treat opioid drug overdoses. The company also entered into a distribution agreement with California to provide naloxone HCI nasal spray through the CalRx Naloxone Access Initiative. Amneal expects to have capacity to produce approximately ten million two-packs annually at its New Jersey manufacturing facility, starting in 2025.

“Amneal is an industry leader in complex generics with the ability to develop, manufacture and commercialize high-quality medicines that are affordable and accessible. The widespread availability of OTC naloxone will be a critical tool in the fight against the ongoing opioid epidemic. Amneal is proud to be part of the solution,” said Andy Boyer, executive vice president, chief commercial officer, generics.

[Read more: Amneal launches generic OTC Narcan Nasal Spray]

“We are pleased to partner with the State of California on a long-term distribution agreement to make OTC naloxone available to thousands of communities and millions of people. We are actively engaging with other states and municipalities to expand access to this important life-saving product, which is proudly made in America in one of our New Jersey facilities,” said Maryll Toufanian, senior vice president of regulatory strategy and government affairs.

[Read more: Amneal debuts 2 generics]