Amneal Pharmaceuticals: FDA accepts ANDA for naloxone hydrochloride nasal spray

Amneal Pharmaceuticals announced the U.S. FDA has accepted for review the Abbreviated New Drug Application 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. According to IQVIA, U.S. annual sales for this product for the 12 months ended December 2022 were $318M. In addition, there are significant volumes of the product purchased directly by U.S. states.