FDA Tentatively Approves Intelliject's Lead Product, E-cue™

Posted by taznetwork at 2:53 AM . Sunday, August 14, 2011

Main Category: Allergy
Also Included In: Regulatory Affairs / Drug Approvals; Pharma Industry / Biotech Industry
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Intelliject, Inc. announced that the U.S. Food and Drug Administration (FDA) 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. According to Spencer Williamson, President and CEO of Intelliject, "e-cue™'s tentative approval is another important step along our journey to empower patients living with serious medical conditions."

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.

About anaphylaxis

Anaphylaxis is a severe allergic reaction that involves a number of body systems and can be fatal within minutes. The American College of Allergy, Asthma and Immunology estimates there are up to 2,000 episodes of anaphylaxis per every 100,000 people in the U.S. each year, although the precise incidence of anaphylaxis is unknown and is likely underreported.

Anaphylaxis can occur in people with allergies to certain foods, insect stings, medications, latex or other allergens. All published national anaphylaxis guidelines recommend epinephrine as the first choice treatment in an acute episode. The vast majority of deaths from anaphylaxis occur in individuals who do not receive epinephrine in a timely manner.

Source: Intelliject, Inc

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