Generic naloxone nasal spray gets green light from FDA

April 22, 2019

Providing another tool to fight the opioid epidemic, FDA cleared the first generic naloxone hydrochloride nasal spray (Narcan) for use in a community setting.

Providing another tool to fight the opioid epidemic, FDA cleared the first generic naloxone hydrochloride nasal spray (Narcan) for use in a community setting.

While FDA granted approval of the first generic naloxone nasal spray for use in a community setting by individuals without medical training to Teva Pharmaceuticals, generic injectable naloxone products have been available for years for use in a healthcare setting, the agency said in a statement.

Related: New naloxone provides more opioid overdose options

FDA also said it would prioritize the review of additional generic drug applications for products intended to treat opioid overdose.

“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 Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in the FDA statement.

“All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most-friends and families of opioid users, as well as first responders and community-based organizations. We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction,” Throckmorton added.

Related: Amid opioid epidemic, FDA clears powerful painkiller

FDA previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training. Plus, US Department of Health and Human Services (HHS) is partnering with Opiant Pharmaceuticals in Santa Monica, California, to develop a fast-acting, long-lasting intranasal form of naloxone called nalmefene.

As part of HHS’ public health emergency to address the ongoing opioid crisis, the FDA will grant priority review to all abbreviated new drug applications for products indicated for the emergency treatment of known or suspected opioid overdose.

“As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency communication with sponsors; and expanded agency engagement similar to Generic Drug User Fee Act enhancements for complex products…” FDA said.

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