The FDA has approved Padagis’s supplemental application for over-the-counter sales of the company’s generic version of Narcan naloxone nasal spray, 4 mg, for the reversal of opioid overdose. Padagis initially launched its generic in the US in June 2022. In February 2023, an FDA advisory committee in favor of over-the-counter use of Narcan, and the agency approved OTC sales of Narcan in March 2023.
Padagis President Pamela Hoffman commented, “This first generic approval of an over-the-counter naloxone nasal spray highlights the innovation and execution capabilities of the Padagis team. Padagis is committed to leveraging our resources and expertise to contribute to the national effort in addressing opioid overdose, a pressing public health issue.”
Read the Padagis press release.
