On Dec. 9, 2025, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is a critical therapy utilized by hospitals, emergency departments and other acute care facilities for patient care.

Epinephrine is a non-selective alpha and beta adrenergic agonist. The 1 mg/mL formulation is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

The most common adverse reactions associated with systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism.