FDA grants final approval for Teva's generic nasal spray formulation of opioid overdose reversal drug naloxone hydrochloride

Teva received final FDA approval for its nasal spray formulation of generic naloxone hydrochloride to stop or reverse the effects of an opioid overdose, the agency announced Friday. The FDA noted that it is the first approval of a generic naloxone nasal spray for use in a community setting by individuals without medical training, although generic injectable naloxone products have been available for years for use in healthcare settings.

Douglas Throckmorton, deputy director for regulatory programmes in the FDA's Center for Drug Evaluation and Research, remarked that "in addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritise our review of generic drug applications for naloxone." He added that the agency is also assisting "manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community."

The FDA cleared the first authorised nasal spray version of naloxone hydrochloride, marketed under the name Narcan, in 2015. Narcan is sold by Emergent BioSolutions, which gained the drug via its acquisition of Adapt Pharma last year. The agency had tentatively approved Teva's generic drug product last June.

In December, an FDA advisory panel voted 12 to 11 in favour of labelling changes for opioids that recommend co-prescribing the pain drugs with naloxone. 

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