BRIDGEWATER, N.J. — December 9, 2025 — Leads & Copy — Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) announced today that the U.S. Food and Drug Administration (FDA) has approved its epinephrine injection USP, 1 mg/mL, in single-dose (1 mL) and multi-dose (30 mL) vials.
According to Arash Dabestani, Pharm.D., Senior Vice President, Institutional, epinephrine is one of the most important and widely used emergency medicines in healthcare. Dabestani stated that the introduction of both single- and multi-dose vial presentations will expand reliable and affordable access for hospitals and clinical providers.
The 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.
Common adverse reactions include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism.
IQVIA® data indicates that U.S. annual sales for epinephrine injection single- and multi-dose vials were approximately $118 million for the 12 months ended October 2025.
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) is a global biopharmaceutical company headquartered in Bridgewater, NJ. It manufactures and distributes over 290 pharmaceuticals primarily within the United States. Amneal is expanding its Affordable Medicines segment across complex product categories and therapeutic areas, including injectables and biosimilars. The Company has a Specialty segment with a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, Amneal distributes pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets.
Investor Contact:
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact:
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com
Source: Amneal Pharmaceuticals, Inc.
