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

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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 this product at a significant scale and substantially increase access to this life-saving medicine as we work to help combat this endemic crisis.”

According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2022 were $318 million. In addition, there are significant volumes of the product purchased directly by U.S. states.

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