Amneal Secures FDA Nod For Dual-Format Epinephrine Injection, Supporting Anaphylaxis And Septic Shock Treatment Nationwide

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its epinephrine injection USP, 1 mg/mL, in two formats: a 1 mL single-dose vial and a 30 mL multi-dose vial. This medication is an essential treatment used widely across hospitals, emergency departments, and other acute care facilities, where it plays a critical role in urgent patient care.

According to Arash Dabestani, Pharm.D., Senior Vice President of Institutional at Amneal, epinephrine remains one of the most vital emergency drugs in the healthcare system. He noted that offering both single-dose and multi-dose vial options will help improve access and affordability for healthcare providers. This approval also reflects Amneal’s ongoing commitment to supplying key medicines that support patient care throughout the U.S. health system.

Epinephrine is classified as a non-selective alpha and beta adrenergic agonist. The 1 mg/mL formulation is approved for the emergency treatment of Type 1 allergic reactions, including anaphylaxis caused by foods, insect stings, medications, diagnostic substances, or other allergens. It is also indicated for idiopathic or exercise-induced anaphylaxis. Additionally, the formulation is used to increase mean arterial blood pressure in adult patients experiencing hypotension related to septic shock.

The most commonly reported side effects of systemic epinephrine include anxiety, restlessness, tremors, weakness, dizziness, sweating, palpitations, nausea, vomiting, headache, and breathing difficulties. These reactions may occur even at recommended doses and are more likely in individuals with hypertension, heart disease, or hyperthyroidism. Full prescribing information is available in the package inserts for both the single-dose and multi-dose vials. IQVIA® data shows that U.S. annual sales for epinephrine injection single- and multi-dose vials were approximately $118 million for the 12-month period ending October 2025.