FDA approves first generic nasal form of naloxone to fight ODs

The approval is part of the FDA's push to make the drug more readily available

Paul Liotta
Staten Island Advance, N.Y.

White Oak, Md. —  The Food and Drug Administration has announced the first approval of a generic version of the anti-overdose drug brand Narcan, a nasally-administered version of naloxone.

Dr. Douglas Throckmorton, deputy center director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said the approval is part of the FDA's push to make the drug more readily available, even assisting manufacturers in their pursuit of an FDA-approved over-the-counter version.

"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," Throckmorton said.

This is the first generic version of nasal spray naloxone, according to a media release from the FDA. The nasal form is more easily administered by those without medical training, according to the FDA.

CDC data shows nearly 400,000 people died from an opioid overdose from 1999 to 2017.

Generic drugmaker Teva Pharmaceutical Industries Ltd received the approval. Teva had already received tentative approval for the drug in June 2018.

"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 said in a statement.


(c)2019 Staten Island Advance, N.Y.

McClatchy-Tribune News Service

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