FDA approves Teva’s generic Narcan nasal spray
The Food and Drug Administration today gave the nod for Teva's naloxone hydrochloride nasal spray, commonly known as Narcan nasal spray, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opiant Pharmaceuticals is the brand manufacturer of Narcan nasal spray.
The agency said it also is planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.
“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, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. "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,”
Teva's is the first generic naloxone nasal spray for use in a community setting by individuals without medical training, but the FDA said generic injectable naloxone products have been available for years for use in a health care setting. The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training. The FDA also held a two-day advisory committee meeting in December to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community.
One of the ways the FDA is working to increase access to this life-saving treatment is through the approval of generic naloxone products. 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, such as pre-submission and midcycle meetings. The FDA has determined that further expanding availability of and access to overdose reversal drugs could help address the public health emergency.
The agency said it also is planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.
“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, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. "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,”
Teva's is the first generic naloxone nasal spray for use in a community setting by individuals without medical training, but the FDA said generic injectable naloxone products have been available for years for use in a health care setting. The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training. The FDA also held a two-day advisory committee meeting in December to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community.
One of the ways the FDA is working to increase access to this life-saving treatment is through the approval of generic naloxone products. 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, such as pre-submission and midcycle meetings. The FDA has determined that further expanding availability of and access to overdose reversal drugs could help address the public health emergency.