Teva Pharma Gets FDA Approval to Market Generic Nasal Spray for Opioid Overdoses

   By Stephen Nakrosis

The U.S. Food and Drug Administration on Friday said it gave approval to Teva Pharmaceutical Industries Inc. (TEVA) to market generic naloxone nasal spray to treat opioid overdoses.

The agency said this was the first approval of generic naloxone nasal spray for use in a community setting by individuals without medical training. The FDA previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.

The FDA also said it intends to prioritize the review of additional generic drug applications for products intended to treat opioid overdoses.

"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," said Dr. Douglas Throckmorton, deputy center director for regulatory programs in the FDA's Center for Drug Evaluation and Research.

According to the Centers for Disease Control and Prevention, almost 400,000 people died from an opioid overdose from 1999 to 2017, the agency said.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

April 19, 2019 11:52 ET (15:52 GMT)

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