Since acquiring the EpiPen® Auto-Injector, Mylan has made significant
improvements to the design of the medical device portion of the
product. In 2009, we launched a next-generation EpiPen® AutoInjector which represented a complex and innovative re-design of the
device. Design enhancements include the "Never See" needle and the
flip-top case. These improvements were aimed at making EpiPen®
Auto-Injectors easier to safely carry, hold, and administer and reduce
the risk to users from the device's needle, which is extremely
important to our patients. Particularly, in light of the fact that these are
devices that children are trained to use in the absence of adult
supervision. Attached is a fact sheet about the product. Further, Mylan
presently is investing substantial amounts in research into additional
improvements, such as a formulation with a longer shelf life that would
extend the period between replacement of unused auto-injectors.
We encourage all patients and caregivers to receive training on proper
administration of their prescribed an epinephrine auto-injector in a
physician’s office and practice between doctor office visits to help
ensure preparedness should a life-threatening allergic reaction
(anaphylaxis) occur. For this reason, training and support have been a
primary focus since the launch of EpiPen® Auto-Injector to help
educate patients and caregivers about the simple, three-step
administration process. Each EpiPen 2-Pak® includes a needle-free,
medication-free Trainer to practice administration technique and
provides two doses of epinephrine to encourage compliance with the
National Institute of Allergy and Infectious Diseases (NIAID) Food
Allergy Guidelines, which recommend two doses of epinephrine be
available at all times for those at risk for anaphylaxis. We offer a “How
To” video on epipen.com, our Official EpiPen® Auto-Injector YouTube®
channel and through the My EpiPlan® app. Additional EpiPen® Trainers
may be ordered on epipen.com.