Intelliject receives FDA Approval for Auvi-Q
Intelliject, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Auvi-Q™ (epinephrine injection, USP) for the emergency treatment of life-threatening allergic reactions in people who are at risk or have a history of anaphylaxis. This is the first-and-only compact auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.
“The FDA approval of Auvi-Q is an important milestone for the company and is a result of our steadfast commitment to developing patient-centric products,” said Spencer Williamson, President and Chief Executive Officer, Intelliject, Inc. “We are building on this approval and have a pipeline of drug/device combination products for select therapy areas.”
“In developing Auvi-Q, our goal is to offer patients and caregivers an innovative treatment option that is easy to use in an emergency,” said Eric Edwards, Chief Science Officer, Intelliject, Inc. “As allergy sufferers, my twin brother and I know first-hand how stressful it can be when you experience a severe allergic reaction. Auvi-Q’s small size and intuitive design, as well as its first-in-class prompt system that talks a user through the injection process, will help patients and caregivers manage a life-threatening allergic reaction.”
Auvi-Q provides users with audible and visual cues for correct use – including a five-second injection countdown and an alert light to signal when the injection is complete. In addition to being an auto-injector, it features an automatic retractable needle mechanism to help prevent accidental needle sticks.
Intelliject, Inc. was responsible for the development and regulatory submission of Auvi-Q in the U.S. Sanofi US is responsible for manufacturing and commercial activities in North America (U.S. and Canada).