The US Food and Drug Administration (FDA) has approved Amphastar Pharmaceuticals, Inc.’s New Drug Application (NDA) for naloxone hydrochloride nasal spray, 4 milligrams, to treat Opioid Overdose.
Naloxone hydrochloride nasal spray 4mg is indicated for the immediate treatment of adult and pediatric patients suffering from respiratory and/or central nervous system depression as a result of a known or suspected opioid overdose.
According to Dr. Jack Zhang, President and Chief Executive Officer of Amphastar, the approval of our naloxone hydrochloride nasal spray is an important step towards easing the opioid crisis because it allows patients to have access to a crucial product in a wider range of settings. Using their imaginative gadget stage, the endorsement of naloxone hydrochloride nasal spray approves our specialized capacities as we can use this for their intranasal pipeline.
According to IQVIA, Naloxone hydrochloride nasal spray 4mg sales in the United States in 2022 were approximately $250 million for the twelve months ending December 31, 2022.
The company has filed three ANDAs with the FDA for products with a market value of more than $3 billion, six generic products with a market value of more than $9 billion, three biosimilar products in development with a market value of more than $11 billion, and three ANDAs for products with a market value of more than $3 billion.
This information about the market is derived from IQVIA data for the year 2022 that ended on December 31. Multiple proprietary products with injectable and intranasal dosage forms are being developed by the company.