Hikma's Epinephrine Nasal Spray Advances Through FDA, EU, UK Review
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London – September 16, 2026 -- Hikma Pharmaceuticals PLC said regulators in the United States, Europe, and the UK have accepted for review its investigational epinephrine nasal spray, a needle-free treatment for anaphylaxis, with an additional filing lodged in Canada.
FDA accepts 505(b)(2) application for non-injectable anaphylaxis treatment
The US Food and Drug Administration has taken up a New Drug Application submitted under the 505(b)(2) pathway, which includes the required non-clinical and clinical data package supporting approval of the nasal spray for emergency anaphylaxis treatment.