FDA Approves Higher Dosage of Naloxone

The Food and Drug Administration recently announced the approval of a higher dose of naloxone nasal spray to treat opioid overdose. The FDA previously approved 2 mg and 4 mg naloxone products and has now approved the delivery of 8 mg of naloxone. As described in the press release, the approval of 8 mg naloxone is another step the agency has taken to improve the availability of naloxone products. The agency has also encouraged manufacturers to pursue approval of over-the-counter naloxone products; required drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to prescribing information; and has extended the shelf life of naloxone from 24 months to 36 months. Read more

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