FDA approves 1st generic nasal spray to treat opioid overdose
U.S. regulators have approved the first generic nasal spray version of Narcan, a drug that reverses opioid overdoses. The Food and Drug Administration gave the green light Friday for naloxone spray from Israel's Teva Pharmaceuticals.
"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. 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," Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said in a statement.
Naloxone has been sold as a nasal spray in the U.S. since 2016 under the brand name Narcan. Pharmacists can dispense it without a prescription. It is also sold as a generic or brand-name drug in automatic injectors, prefilled syringes and vials.
A pack of two Narcan nasal sprays cost about $130 to $150 without insurance. Teva didn't immediately provide the product's price or when it will be available.
More than 47,600 Americans died of opioid overdoses in 2017, a toll that has been rising for two decades.