Amneal Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for its epinephrine injection USP, 1 mg/mL, in both single-dose (1 mL) and multi-dose (30 mL) vials.

阿姆内阿尔制药公司已获得美国食品药品监督管理局 (FDA) 的批准，其肾上腺素注射液 USP（1 毫克/毫升）的单剂量（1 毫升）和多剂量（30 毫升）小瓶均可使用。

Epinephrine is a non-selective alpha and beta adrenergic agonist. The 1 mg/mL formulation is used for the emergency management of allergic reactions, including anaphylaxis caused by allergens such as insect stings, foods, drugs, or diagnostic agents. It is also used to help increase mean arterial blood pressure in adults experiencing hypotension linked to septic shock..

肾上腺素是一种非选择性α和β肾上腺素能激动剂。1毫克/毫升的制剂用于过敏反应的紧急处理，包括由昆虫叮咬、食物、药物或诊断剂等过敏原引起的过敏性休克。它还用于帮助提高因脓毒性休克导致低血压的成人的平均动脉血压。

The medicine is widely used in hospitals, emergency departments, and other acute care settings as an essential treatment option.

该药物广泛应用于医院、急诊科和其他急性护理场所，作为一种基本的治疗选择。

The introduction of both vial formats is expected to support consistent and affordable supply for healthcare facilities, strengthening Amneal’s efforts to provide essential medicines across the U.S. healthcare system.

两种小瓶装的引入预计将会为医疗机构提供稳定且价格合理的供应，加强了Amneal在美国医疗系统中提供基本药物的努力。

Common side effects of systemically administered epinephrine may include anxiety, restlessness, tremors, palpitations, sweating, dizziness, nausea, vomiting, headache, and breathing difficulties. These reactions are more likely in individuals with existing heart conditions, hypertension, or hyperthyroidism..

全身给药的肾上腺素的常见副作用可能包括焦虑、烦躁、震颤、心悸、出汗、头晕、恶心、呕吐、头痛和呼吸困难。这些反应在已有心脏疾病、高血压或甲状腺功能亢进的个体中更有可能发生。

IQVIA data shows that U.S. annual sales of epinephrine injection in single- and multi-dose vials reached approximately USD 118 million for the 12-month period ending October 2025.

IQVIA数据显示，截至2025年10月的12个月内，美国单剂量和多剂量安瓿肾上腺素注射液的年销售额达到约1.18亿美元。

Source: amneal.com

来源：amneal.com