The Food and Drug Administration (FDA) has granted final approval for the first generic version of Narcan (naloxone hydrochloride nasal spray; Adapt Pharma) to Teva Pharmaceuticals. The Agency had granted tentative approval to the Company’s Abbreviated New Drug Application (ANDA) in June 2018.
Naloxone hydrochloride reverses the effects of opioids, including respiratory depression, sedation, and hypotension. In a statement announcing today’s approval, the FDA outlined steps to prioritize the review of additional generic applications “for products intended to treat opioid overdose.”
In addition, the agency is continuing to take action to facilitate the creation of an over-the-counter (OTC) naloxone product. Although approved naloxone formulations have instructions for use in the product labeling, they do not have a consumer-friendly Drug Facts label (DFL), a requirement for OTC products.
To expedite the approval of life-saving naloxone products, the FDA will grant priority review to all ANDAs for products indicated for the emergency treatment of known or suspected opioid overdoses.
“All together, these efforts have the potential to put a vital tool for combating 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,” said Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
For more information visit FDA.gov.