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EpiPens and So-Called “Generic” Versions: The Facts

On June 18, 2010 @ 11:09 am In All Articles

[1]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 [2], 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 [3]. 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:

(800) 429-7751
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 [4]


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:

[1] Image: http://www.aanma.org/wordpress/wp-content/uploads/Epi2.jpg

[2] Mylan Specialty: http://mylanspecialty.com/

[3] Orange Book: Approved Drug Products with Therapeutic Equivalent Evaluations: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

[4] http://www.fda.gov/Safety/MedWatch/default.htm: http://www.fda.gov/Safety/MedWatch/default.htm

[5] News 2 Use – Keep Two Doses of Epinephrine On Hand: http://www.aanma.org/2009/05/keep-two-doses-of-epi/

[6] Fearless Feasting: Remember Anaphylaxis Medication During the Holidays: http://www.aanma.org/2009/12/fearless-feasting-remember-anaphylaxis-medication-during-the-holidays/

[7] Flu Facts: http://www.aanma.org/health-topics/flu-facts/

[8] Facing the Facts: Recognize the Signs of Asthma: http://www.aanma.org/2009/02/facing-the-facts-recognize-the-signs-of-asthma/

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