【中文】2023 年 11 月 15 日获美国 FDA 批准信并实现美国获批上市。FDA 批准适应症：适用于完全或部分逆转阿片类药物的作用，包括由天然或合成阿片类药物引起的呼吸抑制；适用于已知或疑似阿片类药物过量的治疗。
【English】Obtained the FDA approval letter on November 15, 2023, marking its approved launch in the United States. FDA-approved indications: complete or partial reversal of opioid effects, including respiratory depression induced by natural or synthetic opioids, and the treatment of known or suspected opioid overdose.
