Scroll down or Click Here forImportant Safety Information
Scroll down or Click Here forEpinephrine auto-injector devices are used for the emergency treatment of potentially life-threatening anaphylactic reactions, and each has a unique design and operating instructions for use under stressful conditions. It is critical that epinephrine be administered quickly and correctly, without the added confusion of patient or caregiver unfamiliarity with the auto-injector device.2
The Food and Drug Administration (FDA) has rated all epinephrine auto-injectors with an Orange Book rating of “BX,” indicating that insufficient evidence exists to determine therapeutic equivalence. This rating thereby presumes that other epinephrine auto-injector products are not therapeutically equivalent to EpiPen Auto-Injector.3 Only “A”‑rated products are considered bioequivalent, and thus, substitutable.3 If the bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence, the drugs are designated an “AB” rating.3 To date, there are no “AB” rated epinephrine auto-injector devices. Therefore, when presented with a prescription for an EpiPen Auto-Injector, it may be unlawful to dispense a different type of epinephrine auto-injector unless it is an A-rated generic, even if the prescriber indicates that substitution is permitted. There are no A-rated generic EpiPen Auto-Injectors for substitution.
To view the FDA’s Orange Book, please click here.