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As of Nov 13, 2026, NDA 215425 (Epinephrine), held by Fresenius Kabi USA, was first approved by FDA on Mar 13, 2025, with 0 approved supplements and 0 published complete response letters.
First approved: Mar 13, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Epinephrine is a non-selective alpha and beta adrenergic agonist indicated:
For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients.
To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.1 Anaphylaxis Epinephrine Injection is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and pediatric patients. 1.2 Hypotension associated with Septic Shock Epinephrine Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
