The FDA grants final approval for Teva Pharmaceutical Industries’ (NYSE:TEVA) generic version of Adapt Pharma’s NARCAN Nasal Spray (naloxone HCl), an opioid reversal agent designed to be used by someone with no medical training for treating a person who has overdosed.
The agency tentatively approved the drug/device product in June 2018.
Adapt Pharma is a subsidiary of Emergent BioSolutions (NYSE:EBS).
The agency says that it is taking steps to promote the availability of more generic products for the emergency treatment of opioid overdose by granting priority review of marketing applications, more intensive guidance for developers, enhanced communications and shorter timelines. It is also working with manufacturers on a registration path for an over-the-counter version.