Amneal Received Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals
Wednesday, December 10, 2025
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.
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.
The medicine is widely used in hospitals, emergency departments, and other acute care settings as an essential treatment option.
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.
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.
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.
Source: amneal.com
