Mylan Applauds New Federal Legislation to Increase Anaphylaxis Preparedness in Schools

PITTSBURGH, Nov. 14, 2013 /PRNewswire/ -- Mylan Inc. (NASDAQ: MYL) commends federal legislation signed by President Barack Obama yesterday aimed at protecting people living with potentially life-threatening allergies. The School Access to Emergency Epinephrine Act (H.R. 2094), encourages states to adopt laws allowing schools to maintain a supply of "stock," or undesignated, epinephrine – the only first-line treatment for life-threatening allergic reactions (anaphylaxis).

"Recent tragedies have reinforced that when anaphylaxis occurs, every minute matters and immediate access to epinephrine and emergency medical care is crucial. The new federal law is a critical step for improving anaphylaxis preparedness in schools," said Heather Bresch, CEO of Mylan. "We applaud those who worked tirelessly to make this bill a reality – from Congress, government officials and leading advocacy organizations to parents, caregivers, patients and health care professionals."

The passage of this federal legislation demonstrates national, bipartisan support for stock epinephrine policies in the school setting. Stock epinephrine refers to epinephrine auto-injectors that are prescribed to an entity, such as a school, rather than a specific individual, to be used in the event anaphylaxis occurs.

Bresch added, "This legislative milestone inspires us to work even harder on advocating for increased anaphylaxis awareness, preparedness and access to treatment. One of the programs that Mylan is most proud of is our EpiPen4Schools® initiative. As stock epinephrine laws and regulations evolve on a state level, we hope to see continued participation in the EpiPen4Schools program, because even one anaphylactic episode without access to epinephrine is one too many."

Launched in August 2012, Mylan offers the only program of its kind that provides schools, upon qualification, with up to four free EpiPen® (epinephrine) or EpiPen Jr® (epinephrine) Auto-Injectors so they are available in the event a person experiences anaphylaxis in the school setting. To date, more than 30,000 schools have participated in the EpiPen4Schools program. Qualification includes having a valid prescription.

Anaphylaxis causes approximately 1,500 deaths annually, and children and adolescents are among those most at risk. With the rate of food allergies among U.S. children on the rise, now affecting one in 13, preparedness in the school setting is critical. To support schools' preparedness efforts, the Centers for Disease Control and Prevention (CDC) recently released national guidelines for managing food allergies in schools titled, "Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs." These guidelines are intended to support implementation of food allergy management in schools. They provide parents, school administrators and staff practical information, planning steps and strategies for reducing life-threatening allergic reactions, such as allergen avoidance, and responding to anaphylaxis.

Indications
EpiPen® (epinephrine) 0.3 mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate self administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use.

Important Safety Information
EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. DO NOT INJECT INTO YOUR VEIN, BUTTOCK, FINGERS, TOES, HANDS OR FEET. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure and heart disease, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your doctor all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you take the EpiPen or EpiPen Jr Auto-Injector.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest.

Talk to your healthcare professional to see if EpiPen or EpiPen Jr Auto-Injector is right for you.

Please click here for the EpiPen Auto-Injector full Prescribing Information.

Please click here for the EpiPen Auto-Injector Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About Anaphylaxis
Anaphylaxis is a life-threatening allergic reaction that has many possible triggers, occurs quickly, without warning, and must be treated immediately with epinephrine. Symptoms may include hives or redness of the skin, tightness in the throat, nausea, dizziness, breathing problems, a decrease in blood pressure and/or fainting. Anaphylaxis can be caused by triggers such as food, stinging and biting insects, medicines, latex or even exercise. Epinephrine is the only first-line treatment for anaphylaxis. According to the food allergy guidelines developed by the National Institute of Allergy and Infectious Diseases, if experiencing anaphylaxis, a person should use an epinephrine auto-injector and seek immediate emergency medical attention. Carrying an epinephrine auto-injector does not prevent patients from having an anaphylactic reaction; hence, patients must avoid their allergic triggers at all times. Epinephrine is a naturally-occurring hormone, also known as adrenaline, and it should be available at all times to patients at risk. Delays in epinephrine administration have been associated with negative health consequences, even possibly death.

About the EpiPen4Schools® Program
The EpiPen4Schools program was launched in August 2012 to help improve access to epinephrine in the event a person experiences anaphylaxis in the school setting. The program will continue to offer four free EpiPen® or EpiPen Jr® (epinephrine) Auto-Injectors to public and private kindergarten, elementary, middle and high schools in the U.S. Requirements to qualify for this offer include having a valid prescription. The product is available in the form of two EpiPen 2-Pak® cartons, two EpiPen Jr 2-Pak® cartons or one 2-Pak of each kind. EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. EpiPen and EpiPen Jr are intended for immediate self administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use. For complete program details, visit www.EpiPen4Schools.com.

To participate in EpiPen4Schools, a school nurse or other authorized school representative must visit www.EpiPen4Schools.com to download the order and certification form, then fax or email the form with a valid prescription to 1-973-718-4328 or info@bioridgepharma.com. Alternately, school representatives can call 1-973-845-7600 to speak with a live representative.

In addition to the EpiPen4Schools program, Mylan Specialty offers a discount program through which schools can purchase, upon qualification, EpiPen 2-Pak cartons and EpiPen Jr 2-Pak cartons at a discounted price. There is no requirement for a school to purchase additional EpiPen Auto-Injectors or any other Mylan Specialty products.

About EpiPen® Auto-Injector
EpiPen Auto-Injectors are used for the emergency treatment of life-threatening allergic reactions. Each EpiPen 2-Pak® contains two single auto-injectors, instructions for use and a training device, with no drug product or needle, to help patients become familiar with the administration technique. EpiPen Auto-Injector should be administered immediately at the first sign of an anaphylactic reaction. EpiPen Auto-Injector is not a substitute for emergency medical treatment. Patients should seek emergency medical attention immediately following administration. For more information about EpiPen Auto-Injector, please visit www.epipen.com.

About Mylan Specialty
Mylan Specialty, a subsidiary of Mylan Inc. (NASDAQ: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, life-threatening allergic reactions and psychiatric disorders. For more information, please visit www.mylanspecialty.com.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,200 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

EpiPen®, EpiPen Jr®, EpiPen 2-Pak® and EpiPen Jr 2-Pak® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned subsidiary, Mylan Specialty L.P. EpiPen4Schools® is a registered trademark of Mylan Inc.

© 2013 Mylan Specialty L.P. All rights reserved.

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SOURCE Mylan Inc.



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