According to Amneal Pharmaceuticals, the FDA has accepted the company’s ANDA for a generic version of Narcan naloxone nasal spray, 4 mg, for the treatment of opioid overdose.
Amneal generics Chief Commercial Officer Andy Boyer said, “Naloxone hydrochloride nasal spray is a critical tool in addressing the opioid public health emergency across the United States. We are well prepared to launch this product at a significant scale and substantially increase access to this life-saving medicine as we work to help combat this endemic crisis.”
Narcan was originally approved by the FDA in 2015. An FDA advisory committee recently recommended approval of Emergent BioSolution’s sNDA for Narcan for over-the-counter use. Teva launched a generic of the nasal spray in December 2021 and Padagis launched its version in June 2022.
Harm Reduction Therapeutic’s NDA for ReVive 3 mg naloxone nasal spray is also under review by the FDA and Orexo recently submitted an NDA for OX124 high dose intranasal dry powder naloxone.
Read the Amneal Pharmaceuticals press release.
