Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals

Core Insights - Amneal Pharmaceuticals has received FDA approval for its epinephrine injection USP, available in both single-dose and multi-dose vials, enhancing its injectables portfolio and addressing critical healthcare needs [1][2] Product Details - The approved epinephrine injection is essential for emergency treatment of allergic reactions, including anaphylaxis, and for increasing mean arterial blood pressure in adults with septic shock [2] - The formulation is available in two presentations: 1 mg/mL in single-dose vials and 1 mg/mL in 30 mL multi-dose vials [1] Market Context - According to IQVIA, the U.S. annual sales for epinephrine injection in both single- and multi-dose vials reached approximately $118 million for the 12 months ending October 2025 [4] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 290 pharmaceuticals, focusing on injectables and biosimilars in its Affordable Medicines segment [5]