Amneal Pharmaceuticals (AMRX) Announces FDA Filing Acceptance of Abbreviated NDA for Naloxone Hydrochloride Nasal Spray, USP, 4mg

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Go back to Amneal Pharmaceuticals (AMRX) Announces FDA Filing Acceptance of Abbreviated NDA for Naloxone Hydrochloride Nasal Spray, USP, 4mg

Amneal Announces U.S. FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Hydrochloride Nasal Spray, USP, 4mg

March 2, 2023 6:01 AM EST

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.

Naloxone hydrochloride nasal spray is a critical tool in addressing the opioid public health emergency across the United States, said Andy Boyer, Chief Commercial Officer, Amneal Generics. We are well prepared to launch... More