addiction recovery ebulletin Naloxone FDA Approved
April 19, 2019 – “In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible,” Douglas Throckmorton, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone.”
Though naloxone has been off-patent since the 1980s, various companies have patented and gotten FDA approval for different versions of drug delivery. Teva’s product is the first naloxone nasal spray generic approved for community use with no medical training, for example, but the brand-name version (Adapt Pharma’s Narcan) is already approved for that same use, as is a branded auto-injectable version (Kaleo’s Enzio).
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