Teva Pharma Gets FDA Approval to Market Generic Nasal Spray for Opioid Overdoses
20 April 2019 - 2:07AM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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