Amneal Pharmaceuticals, Inc. (AMRX) announced that the U.S. FDA has approved its Epinephrine injection USP, 1 mg/mL, in both single-dose and multi-dose for use in U.S. hospitals.
Epinephrine is a non-selective alpha- and beta-adrenergic agonist and one of the most essential emergency medicines in hospital and acute care settings. The 1mg/mL formulation is used for the rapid treatment of severe allergic reactions, including anaphylaxis caused by insect stings, foods, drugs, or other allergens, as well as idiopathic or exercise-induced anaphylaxis. It is also used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
The FDA approval covers two presentations: a 1 mg/mL (1 mL) single-dose vial and a 1 mg/mL (30 mL) multi-dose vial. By offering both formats, Amneal aims to expand reliable and affordable access to this essential therapy for hospitals, emergency departments, and other acute care facilities.
Safety data indicate that common adverse reactions to systemically administered Epinephrine including anxiety, restlessness, tremor, dizziness, sweating, palpitations, nausea, headache, and respiratory difficulties. These effects are more likely in patients with heart disease, hypertension, or hyperthyroidism.
According to IQVIA Holdings Inc., the U.S. annual sales for epinephrine injection single- and multi-dose vials for the 12 months ended October 2025 were approximately $118 million, underscoring the importance of this market.
This approval strengthens Amneal's injectables portfolio and reinforces its commitment to supplying essential medicines across the U.S. health system. AMRX closed yesterday's trading at $11.97, up 0.84%, and rose further in overnight trading to $12.02, up 0.42%. Over the past 12 months, the stock has traded between $6.68 and $12.12.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.