On July 29, 2011 Intelliject, Inc. received notice from the U.S. Food and Drug Administration (FDA) that it has granted tentative approval for the company’s New Drug Application (NDA) for a novel epinephrine auto-injector, e-cue™, for emergency treatment of allergic reactions including anaphylaxis.
The tentative approval of e-cue™ following a first cycle, 10 month review by the FDA provides validation of Intelliject’s vision of developing patient-centric products and of the company’s ability to execute. e-cue™’s tentative approval is another important step along Intelliject’s journey to empower patients living with serious medical conditions.
The Intelliject team – working closely with their network of world class partners – developed and built the product, ran the studies and produced the regulatory dossier. We see this “first review cycle” approval – 10 months from initial submission – as powerful validation of both the platform and the strong execution by the team.
Obtaining a tentative approval means that the product review is complete and the submission met the FDA’s requirements to be approved. 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, Inc. (King) and Meridian Medical Technologies, Inc. (Meridian). Final FDA approval is required before a product can be marketed in the United States.
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.