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EpiPens and So-Called “Generic” Versions: The Facts
On June 18, 2010 @ 11:09 am In All Articles,Medications
Recent news reports have presented patients with conflicting and confusing information about EpiPen Auto-Injector and a so-called generic version. These articles contain information that is inaccurate, inflammatory and, in some instances, dangerous.
Mylan Specialty , the company that makes EpiPen, has issued a statement saying:
· There is no generic version of the EpiPen Auto-Injector product on the market.
· The U.S. Food and Drug Administration (FDA) has not approved a generic version of the EpiPen Auto-Injector.
· No product available to patients in the U.S. has been found by the FDA to be therapeutically equivalent to the EpiPen Auto-Injector.
FDA: BX rating means that there is no product that is therapeutically equivalent to EpiPen. The FDA assigns ratings to products in its Orange Book: Approved Drug Products with Therapeutic Equivalent Evaluations . These ratings let healthcare providers and patients know whether any other products can be used as a substitute (or generic) for the brand-name product.
EpiPen Auto-Injector has a BX rating, which means that there’s insufficient data to determine whether any other products can be used as therapeutically equivalent generics.
Background. The confusion comes in because patients using Twinject – a product made by Sciele Pharma that delivered two doses of epinephrine in one pen – were experiencing technical difficulties with the product. Sciele repurposed Twinject as Adrenaclick, which dispenses one dose of epinephrine. A company called Greenstone makes a product – labeled “auto-injectable epinephrine” – that the FDA deemed to be a legitimate generic substitute for Adrenaclick. However, neither product is an FDA-approved generic for EpiPen.
In a recent update to its Orange Book, the FDA gave BX ratings to Twinject, Adrenaclick and its generic version labeled “epinephrine auto-injector.”
From Dey’s statement:
“It may be unsafe, and may be unlawful in certain circumstances, for a pharmacist to dispense a different type of epinephrine auto-injector that is not A-rated when presented with a prescription specifying an EpiPen Auto-Injector.”
If your healthcare provider has prescribed EpiPen Auto-Injector and your pharmacist dispenses another product, contact your healthcare provider.
Patients with issues or questions can contact Dey’s Medical Affairs/Customer Service office:
Mon. – Fri., 9 a.m. – 7 p.m. ET
Report negative side effects of prescription drugs to the FDA:
(800) 332-1088 or http://www.fda.gov/Safety/MedWatch/default.htm 
Article printed from Allergy and Asthma Network Mothers of Asthmatics: http://www.aanma.org
URL to article: http://www.aanma.org/2010/06/epipens-and-so-called-generic-versions-the-facts/
URLs in this post:
 Image: http://www.aanma.org/wordpress/wp-content/uploads/Epi2.jpg
 Orange Book: Approved Drug Products with Therapeutic Equivalent Evaluations: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
 http://www.fda.gov/Safety/MedWatch/default.htm: http://www.fda.gov/Safety/MedWatch/default.htm
 News 2 Use – Keep Two Doses of Epinephrine On Hand: http://www.aanma.org/2009/05/keep-two-doses-of-epi/
 Fearless Feasting: Remember Anaphylaxis Medication During the Holidays: http://www.aanma.org/2009/12/fearless-feasting-remember-anaphylaxis-medication-during-the-holidays/
 In the Know, In Control – Epi Everywhere! Every Day!™: http://www.aanma.org/2012/08/in-the-know-in-control-%e2%80%93-epi-everywhere-every-day%e2%84%a2/
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