2023-03-08 06:05:37 ET
- Amphastar Pharmaceuticals ( NASDAQ: AMPH ) announces that the FDA has granted approval of its New Drug Application (NDA) for naloxone hydrochloride nasal spray 4mg.
- Naloxone hydrochloride nasal spray 4mg is 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 ~$250M for the 12 months ended December 31, 2022.
For further details see:
FDA approves Amphastar Pharma's naloxone hydrochloride nasal spray 4mg