Intelliject out of Richmond, Virginia received tentative FDA approval for its e-cue epinephrine autoinjector.
The front of the device is the size of a credit card and its thickness is about that of a small cell phone so that it can be easily carried for dealing with potential allergy induced emergencies.
A bit from the press release about why this is a tentative approval:
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.
Press release: FDA Tentatively Approves Intelliject’s Lead Product, e-cue™…
Flashback: EpiCard Wants to Be EpiPen 2.0
