Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has been awarded FDA approval for Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. This is the first generic naloxone hydrochloride nasal spray that the FDA has approved.
FDA deputy center director for regulatory programs Center for Drug Evaluation and Research Douglas Throckmorton said, “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."
He added, " The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death."
A pack of two branded Narcan nasal sprays cost about $130 to $150 without insurance. Teva has yet to say how much the generic version will cost.
Published by Globes, Israel business news - en.globes.co.il - on April 21, 2019
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