Navigation Links
FDA Tentatively Approves Intelliject's Lead Product, e-cue™
Date:8/1/2011

RICHMOND, Va., Aug. 1, 2011 /PRNewswire/ -- Intelliject, Inc. today 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 Intelliject

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.

Intelliject is a privately-held company headquartered in Richmond, Virginia.

For online information please visit www.intelliject.com.

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.

Intelliject Disclaimer: In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Intelliject's current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; and other statements regarding matters that are not historical facts. Some of these forward-looking statements may be identified by the use of words in the statements such as "estimate," "intend," or other words and terms of similar meaning. Statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Intelliject cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Intelliject undertakes no obligations to update or revise these statements, except as may be required by law.

Media Contact:
Jenn Riggle
757/640-1982  ext. 25
757/615-6099 (cell)
jriggle@crt-tanaka.com


'/>"/>
SOURCE Intelliject, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves New Medicine BRILINTA™ (Ticagrelor) for Use in the US
2. FDA Approves Vaccines for the 2011-2012 Influenza Season
3. FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People
4. FDA Approves Arcapta Neohaler to Treat Chronic Obstructive Pulmonary Disease
5. FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
6. FDA Approves Lazanda® - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
7. FDA Approves First Generic Versions of the Antibiotic Levofloxacin to Treat Certain Infections
8. FDA Approves Nulojix for Kidney Transplant Patients
9. FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
10. FDA Approves First Ceramic-on-Metal Total Hip Replacement System
11. FDA Approves Redesigned Labels for Some Merck Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... , April 29, 2016 ... Review, H1 2016" market research report that provides ... with comparative analysis at various stages, therapeutics assessment ... of administration (RoA) and molecule type, along with ... It also reviews key players involved in the ...
(Date:4/29/2016)... , April 29, 2016 ... for Life Sciences, Product Development Capabilities in ... Science Customer Base . Indegene ... today announced the acquisition of Skura Corporation,s life ... leader in adaptive sales enablement technology for life ...
(Date:4/29/2016)... 2016 Interview ... Sanofi, leader mondial et diversifié ... pour le premier trimestre 2016. Le ... commente les résultats du premier trimestre ... le reste de l,année. ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... , ... Spine Team Texas, a comprehensive spine physician group specializing in the ... has been invited to be a featured speaker at the Texas Society of the ... 30, 2016. , Dr. R. Scott McPherson, a physical medicine and rehabilitation specialist, ...
(Date:4/29/2016)... ... April 29, 2016 , ... Mobility Designed is redefining mobility with their ... the M+D Crutch evenly distributes body weight from the elbow to the forearm. ... the crutches than with other crutches. , Co-founders Max and Liliana Younger were inspired ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... Celiac Association (CCA), is pleased to announce the launch of the GFCP ... articles, recipes, and more. The purpose of the GFCP Scoop site ...
(Date:4/29/2016)... ... 29, 2016 , ... Dr. Robert Mondavi, one of the dentists in ... is a fast-growing field as more patients are discovering the many different ways they ... the options currently available to them and which ones might work for their smiles. ...
(Date:4/29/2016)... Hills, CA (PRWEB) , ... April 29, 2016 , ... ... of devices and products for the head and neck/ear, nose and throat specialty, has ... Device , The KOTLER NASAL AIRWAY™ is a newly patented safety device ...
Breaking Medicine News(10 mins):