Kaleo said today that despite ongoing manufacturing delays reported by epinephrine auto-injector manufacturers, Kaleo’s Auvi-Q device is available via prescription and that the privately-held company has ‘sufficient supply to meet any anticipated demand.’
Kaleo’s epinephrine auto-injector features voice instructions that guide users through the drug-delivery process and an auto-retractable needle system, according to the company.
“We understand how critically important it is for those affected by life-threatening allergies to be able to access an epinephrine auto-injector, especially as families prepare for the back to school season. Kaléo is able to fill, and is filling, all the Auvi-Q orders through our direct delivery service at www.auvi-q.com,” Phil Rackliffe, GM of Kaleo’s allergy & pediatrics unit, said in prepared remarks. “It’s important to note that patients must obtain Auvi-Q through the direct delivery service to ensure delivery to their home or healthcare provider’s office and the best expiration dating for Auvi-Q.”
Earlier this year, a survey from the advocacy group Food Allergy Research & Education found that hundreds of people across the U.S. have had trouble getting an Epipen.
Mylan (NSDQ:MYL), which distributes the emergency allergy auto-injector, reportedly told the FDA months ago that manufacturing delays experienced by its partner, Pfizer’s Meridian Medical Technologies, were straining its Epipen supply.
Updated 8/14 to reflect that Mylan does not make the Epipen device.
Intuitive Surgical enjoyed a nearly two-decade monopoly in the robot-assisted surgery space. At DeviceTalks West, we'll delve into that history as longtime CEO Gary Guthart tells us how he got his start in medtech, how Intuitive came to enjoy such a commanding lead and what the future holds for medical robotics.
Use code GUTHART to save an additional 10%.