On Mar. 8, 2023, Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had granted approval of its New Drug Application for naloxone hydrochloride nasal spray 4mg, which is delivered utilizing the Company’s proprietary nasal delivery device.

Naloxone hydrochloride nasal spray 4mg was indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adult and pediatric patients.

According to IQVIA, the U.S. sales of naloxone hydrochloride nasal spray 4mg in 2022 was approximately $250 million for the 12 months ended December 31, 2022.

The Company currently has three ANDAs on file with the FDA targeting products with a market size of over $3 billion, three biosimilar products in development targeting products with a market size of over $11 billion, and six generic products in development targeting products with a market size of over $9 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2022.

The Company is developing multiple proprietary products with injectable and intranasal dosage forms. Amphastar’s Chinese subsidiary, ANP, currently has 17 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.