Mylan subsidiary to exclusively offer EpiPen 2-Pak and EpiPen Jr 2-Pak Auto-Injector

Aug 24 2011

Dey Pharma, L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL), today announced that Dey will exclusively offer the EpiPen 2-Pak® and EpiPen Jr 2-Pak® (epinephrine) Auto-Injector 0.3/0.15 mg, to encourage physicians and patients to follow recommendations by the National Institute of Allergy and Infectious Diseases (NIAID). While there is no safety issue with the EpiPen® and EpiPen Jr single package, Dey will transition away from distributing and marketing these configurations in the U.S.

The "Guidelines for the Diagnosis and Management of Food Allergy in the United States," which were developed by an expert panel sponsored by the NIAID, a division of the National Institutes of Health (NIH), recommend that patients at risk for or who have experienced anaphylaxis have immediate access to two doses of epinephrine. More specifically, the guidelines indicate that if a patient responds poorly to the initial dose or has ongoing or progressive symptoms despite initial dosing, repeated dosing may be required after five to 15 minutes.  Patients should seek immediate emergency medical treatment after use of EpiPen or EpiPen Jr.

Mylan President Heather Bresch commented: "Many people may not be aware that recent food allergy guidelines state that patients at risk for or who have experienced anaphylaxis should have immediate access to two doses of epinephrine. The decision to exclusively offer the EpiPen 2-Pak, which contains two single EpiPen Auto-Injectors, aligns with these guidelines, as well as with the 2011 World Allergy Organization (WAO) anaphylaxis guidelines which recommend that physicians consider prescribing more than one epinephrine auto-injector.  Mylan and Dey are committed to increasing the overall awareness of being prepared for a potentially life-threatening allergic reaction."

Dr. Phillip Lieberman, Clinical Professor of Medicine and Pediatrics at University of Tennessee College of Medicine, and member of the NIAID-sponsored expert panel added: "The guidelines recognize that up to 20% of those who receive epinephrine will require more than one dose before symptoms are relieved. In addition, the need for additional epinephrine cannot be reliably predicted at the onset of a reaction. Therefore, consistent with the guidelines, patients prescribed an epinephrine auto-injector should be given a prescription which allows two doses."  

Each EpiPen 2-Pak contains an EpiPen Auto-Injector training device to help patients become comfortable with administration. The training device contains no drug product or needle.

Dey is no longer shipping single EpiPen Auto-Injector package configurations in the U.S.; however, the single EpiPen Auto-Injector may still be available at certain pharmacies for a few weeks until their stock is depleted. The single EpiPen Auto-Injector package configuration will continue to be available outside of the U.S.

SOURCE Mylan Inc.