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]

Health Literacy Crisis - Healthcare system faces a crisis of health literacy, impacting vulnerable families who rely on emergency services due to lack of awareness of other options [6][14] - A survey revealed that 53% of 523 families, caregivers, and parents could not correctly differentiate between a healthcare emergency versus a non-emergency [16] - Families from underprivileged and minoritized backgrounds were often unaware that urgent care was an option [16] Overutilization of Emergency Rooms - Annually, 75% to 105% million pediatric emergency visits are non-emergent, suitable for urgent care, primary care, or home care [9] - Hospitals experience $250 to 300 cases of overutilization monthly, resulting in approximately $1,200 out-of-pocket costs per family and $370,000 in wasted healthcare dollars annually [11] - Overutilization leads to 1,500 wasted care hours each month, impacting care for true medical emergencies [12] Proposed Solution: Education and Empowerment - Implementing a traffic light system (red for emergencies, yellow/orange for urgent care, green for primary care) increased understanding of affordable healthcare options by 68% [18][19][20] - Healthcare institutions and policymakers should prioritize health literacy programs in schools, clinics, and discharge protocols [23] - Communities and families should advocate for resources that enable informed healthcare decisions [24]