FDA Tentatively Approves Intelliject's Lead Product e-cue
Intelliject, Inc. recently announced the US FDA has granted tentative approval for the company’s 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 our journey to empower patients living with serious medical conditions,” said Spencer Williamson, President and CEO of Intelliject
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. (
Intelliject is confident that the pending patent disputes with King and
Intelliject is a specialty pharmaceutical company dedicated to developing drug/device combination products that empower patients to gain freedom from their medical conditions. Each Intelliject product combines an established drug with an innovative delivery platform with the goal of achieving superiority, patient preference, and cost effectiveness.
Intelliject applies rigorous selection criteria to identify areas where its patient-centric approach and proprietary technology will offer superior solutions. The company only proceeds to an active development program once it has established that incremental clinical and economic benefit is achievable.
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