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news.Intelliject has received the US Food and Drug Administration (FDA) tentative approval for the novel epinephrine auto-injector e-cue's new drug application (NDA) as an emergency treatment for allergic reactions including anaphylaxis.
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The FDA reserves final approval of the product, however, until all exclusivity or patent challenges have been resolved, specifically the current patent litigation brought against Intelliject by King Pharmaceuticals and Meridian Medical Technologies.
Intelliject is confident that the pending patent disputes with King and Meridian will be favorably resolved and looks forward to obtaining final FDA approval and to e-cue’s subsequent availability.
Intelliject president and CEO Spencer Williamson said e-cue’s tentative approval is another important step to empower patients living with serious medical conditions.