The FDA has announced the final approval of Teva’s ANDA for a generic naloxone hydrochloride nasal spray. According to the announcement, the agency tentatively approved the ANDA in June 2018.
Opiant Pharmaceutical’s Narcan nasal spray was approved in a 4 mg dose version by the FDA in November 2015, and a 2 mg dose version of Narcan was approved in January 2017. Adapt Pharma acquired the US rights to Narcan in 2014; Adapt was later acquired by Emergent Biosolutions.
The Teva ANDA was initially filed in July 2016 and Opiant filed suit in October 2016. Perrigo also filed an ANDA for a naloxone nasal spray in 2018, and Opiant quickly filed suit.
The FDA has encouraged development of generic versions of Narcan nasal spray and earlier this year published a model drug facts label for naloxone nasal spray, saying, “In short, we’ve crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access.”
FDA Center for Drug Evaluation and Research Deputy Center Director for Regulatory Programs Douglas Throckmorton commented, “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. The FDA has also taken the unprecedented step of helping to assist 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, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death.”
He continued, “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.”
Read the FDA press release.
