19 April 2019 - Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to help reduce opioid overdose deaths, increase access to emergency treatment.
The U.S. FDA today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose.
The FDA tentatively approved this generic drug product on 8 June 2018. Teva Pharmaceuticals USA Inc. has received final FDA approval to market generic naloxone nasal spray.