The Food and Drug Administration Friday approved the first generic naloxone nasal spray, an emergency treatment for opioid overdose intended for use in the community. Generic injectable naloxone products have been available for use in health care settings for years. The FDA has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training. “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 Douglas Throckmorton, M.D., deputy center director for regulatory programs at the FDA’s Center for Drug Evaluation and Research.

Related News Articles

Headline
A Health Affairs study published Sept. 2 found that less than 40% of Medicare beneficiaries with opioid use disorder received standard care in alignment with…
Headline
The AHA and Federation of American Hospitals Aug. 8 filed an amicus brief in the U.S. District Court for the Eastern District of Texas in support of the U.S.…
Headline
President Trump Aug. 7 issued an executive order, “Improving Oversight of Federal Grantmaking,” requiring government agencies to review new and discretionary…
Headline
The Food and Drug Administration July 31 announced that it is requiring safety label changes to all opioid pain medications to further emphasize and explain…
Headline
The Centers for Medicare & Medicaid Services July 15 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system…
Headline
AHA May 23 submitted recommendations to the Department of Justice and Federal Trade Commission in response to the agencies’ requests for information on…