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Hikma says FDA accepts epinephrine nasal spray application for review

PUBT·09/10/2026 18:20:27
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Hikma says FDA accepts epinephrine nasal spray application for review
  • Regulators accepted for review filings for Hikma’s investigational epinephrine nasal spray for emergency treatment of anaphylaxis.
  • FDA took in a 505(b)(2) New Drug Application for the US market.
  • Europe, UK reviews started via a validated hybrid marketing authorization dossier through DCP, National Procedure.
  • Canada submission filed; additional markets planned.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Hikma Pharmaceuticals plc published the original content used to generate this news brief via PR Newswire (Ref. ID: 202609101420PR_NEWS_USPR_____NY45190) on September 10, 2026, and is solely responsible for the information contained therein.