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药物研发商Amneal宣布OTC盐酸纳洛酮鼻腔喷雾剂获得FDA批准,用于治疗阿片类药物过量紧急情况

Amneal Secures FDA Approval for OTC Naloxone Hydrochloride Nasal Spray to Treat Opioid Overdose Emergencies

PHARMA FOCUS ASIA | 2024-04-25 | 翻译由动脉网AI生成,点击反馈

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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has unveiled its Over the Counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, after securing Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA). This nasal spray, produced domestically by Amneal, serves as a generic alternative to the widely used OTC NARCAN® HCI Nasal Spray, crucial for treating opioid overdoses triggered by substances like heroin, fentanyl, and prescription opioids.The Co-Chief Executive Officers, Chirag and Chintu Patel, expressed their satisfaction in aiding the ongoing public health crisis by making naloxone nasal spray available without prescription and at an affordable cost.

Amneal Pharmaceuticals,Inc.(纳斯达克:AMRX)在获得美国食品和药物管理局(FDA)的简化新药申请(ANDA)批准后,推出了4mg非处方药盐酸纳洛酮(Naloxone HCI)鼻喷雾剂USP。这种由Amneal国内生产的鼻喷雾剂是广泛使用的OTC NARCAN®HCI鼻喷雾剂的通用替代品,对于治疗海洛因,芬太尼和处方阿片类药物引发的阿片类药物过量至关重要。联合首席执行官Chirag和Chintu Patel表示,他们对帮助持续的公共卫生危机感到满意,他们无需处方,以负担得起的成本提供纳洛酮鼻喷雾剂。

They underscored Amneal's commitment to assisting communities and families in averting further tragedies associated with opioid overdose.Statistics indicate that a significant portion of drug overdose fatalities involve illicit synthetic opioids, particularly fentanyl, surpassing other causes of death among individuals under 50.

他们强调Amneal致力于帮助社区和家庭避免与阿片类药物过量相关的进一步悲剧。统计数字表明,药物过量死亡的很大一部分涉及非法合成阿片类药物,特别是芬太尼,超过了50岁以下个体的其他死亡原因。

According to the Centers for Disease Control and Prevention, almost half of overdose deaths occur in the presence of another person who has the potential to intervene.Amneal's Naloxone HCI Nasal Spray is now available, aiming to expand access to this emergency treatment option. Commercial sales data from IQVIA® reveals substantial annual sales for NARCAN® Naloxone HCl Nasal Spray, with additional procurement by U.S.

根据疾病控制和预防中心的数据,几乎一半的过量死亡是在另一个有可能干预的人在场的情况下发生的。Amneal的盐酸纳洛酮鼻喷雾剂现已上市,旨在扩大这种紧急治疗选择的范围。IQVIA®的商业销售数据显示,NARCAN®盐酸纳洛酮鼻喷雾剂的年销售额可观,美国也有额外采购。

states and municipalities.Naloxone Nasal Spray is designed to swiftly counteract the effects of opioid overdose by binding to opioid receptors, restoring normal breathing within minutes. It contains the same active ingredient and dosage as NARCAN® Naloxone HCI Nasal Spray and is user-friendly and safe for use even when opioids a.

州和市。纳洛酮鼻喷雾剂旨在通过与阿片受体结合,在几分钟内恢复正常呼吸,从而迅速抵消阿片类药物过量的影响。它含有与NARCAN®Naloxone HCl鼻喷雾剂相同的活性成分和剂量,即使在阿片类药物a的情况下,它也是用户友好且安全的。

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