(Reuters) – Generic drugmaker Teva Pharmaceutical Industries Ltd on Friday received approval from the U.S. Food and Drug Administration (FDA) to market its generic nasal spray for opioid overdose, the health regulator said.
This is the first approval of a generic naloxone nasal spray for use in a community setting by individuals without medical training, the FDA said in a statement.
Almost 400,000 people died from an opioid overdose from 1999 to 2017, the regulator said, citing data from the Centers for Disease Control and Prevention.
The FDA had tentatively approved Teva’s generic naloxone nasal spray in June last year.
(Reporting by Ankit Ajmera in Bengaluru; Editing by Chizu Nomiyama)