WASHINGTON — The U.S. Food and Drug Administration on Thursday announced the approval of the first generic version of EpiPen.
The auto-injector pen delivers the drug epinephrine to patients experiencing a severe allergic reaction that, if untreated, could develop into the life-threatening condition anaphylaxis. The medication is delivered into a muscle as a single dose, like a shot, through an injector pen with a spring.
Allergies from food, bug bites, medications and latex can cause life-threatening reactions.
The newly approved generic is made by Teva Pharmaceuticals and offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen made by Mylan. It is approved in a smaller dose for children, as well.
There two other brand products on the market for severe allergic reaction: Adrenaclick and Auvi-Q.
The newly approved option made by Teva is the only approved non-brand option and can be substituted only for Mylan’s EpiPen.
“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” FDA Commissioner Dr. Scott Gottlieb said in a statement announcing the approval.
In recent years, Mylan came under fire for a price increase that put the product out of reach for many who needed to keep the drug on hand.