Dey Launches And Unveils Next-Generation, Needle-Protected EpiPen(R) (Epinephrine) Auto-Injector With Enhanced Patient-Friendly Features

Main Category: Allergy
Also Included In: Medical Devices / Diagnostics;  Pharma Industry / Biotech Industry
Article Date: 29 Oct 2009 - 3:00 PDT

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Dey Pharma, L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL - News), launched a newly designed, patient-friendly EpiPen® Auto-Injector 0.3/0.15 mg. This next-generation EpiPen Auto-Injector maintains the simplicity, speed, safety and reliability of EpiPen Auto-Injector with several new, user-friendly features, including being the only auto-injector with needle-protection before and after use.

Dey President Carolyn Myers, Ph.D., said: "We are very pleased to be launching Dey's highly anticipated next-generation, needle-protected EpiPen Auto-Injector. The objective of the product's new features is to give those who carry an epinephrine auto injector some additional peace of mind when it comes to the risk of anaphylaxis. We also hope that those who are at risk of anaphylaxis but currently don't carry an epinephrine auto injector will become as prepared as possible for the risk of allergen exposure."

EpiPen Auto-Injector is the number one prescribed first-line emergency auto-injector for potentially life-threatening allergic reactions known as anaphylaxis. Anaphylaxis can occur when people with allergies to food, insect stings, latex or other allergens come in contact with that allergen. Immediate access to epinephrine is critical during the first few minutes of an anaphylactic reaction.

"Prompt administration of epinephrine during a severe allergic reaction helps save lives so it's important that people not only have immediate access to a self-injected epinephrine but know how to properly use it," said Dr. Phil Lieberman, Clinical Professor of Medicine and Pediatrics, University of Tennessee College of Medicine. "This new EpiPen Auto-Injector offers enhancements to make it easier for people to administer epinephrine quickly and properly in an emergency situation."

The next-generation EpiPen Auto-Injector introduces built-in needle protection, making EpiPen the only epinephrine auto-injector with no exposed needle before and after use. Other benefits of the re-designed EpiPen Auto-Injector include:

An ergonomically-designed, easy-to-grasp oval barrel with illustrated instructions that allow for rapid understanding and proper use of EpiPen Auto-Injector. The oval shape also prevents the device from rolling out of reach during an emergency; one-step flip-top carry case that allows for rapid, single-handed removal; bright orange colors and arrows to help quickly identify the needle end of the device and reduce the risk of accidental thumb puncture.

Importantly, any patient that currently carries or has recently received an EpiPen or EpiPen Jr. Auto-Injector should continue to carry that EpiPen Auto-Injector until their current pen is used or reaches its expiration date. Upon renewal of their next EpiPen Auto-Injector prescription, patients will automatically receive the next generation EpiPen Auto-Injector.

About Anaphylaxis

Anaphylaxis is a severe allergic reaction that involves a number of body systems and can be fatal within minutes, either through swelling that shuts off airways or through a significant drop in blood pressure. Anaphylaxis occurs in people with allergies to certain foods, insect stings, medications, latex or other allergens. As many as 15% of Americans - up to 12 million people - have an allergy that may put them at risk for anaphylaxis. There are up to 2,000 episodes of anaphylaxis per every 100,000 people in the U.S. each year. The precise incidence of anaphylaxis is unknown because this serious, life-threatening condition is believed to be underreported. The vast majority of deaths from anaphylaxis occur in individuals who do not receive epinephrine in time.

About EpiPen Auto-Injector

EpiPen and EpiPen Jr. (0.3 and 0.15 mg epinephrine) Auto-Injectors are for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for patients who are at increased risk for these reactions.

EpiPen and EpiPen Jr. Auto-Injectors are designed for you to use immediately in an emergency, to treat an allergic reaction fast and give you time to get to a hospital or medical center. EpiPen and EpiPen Jr. Auto-Injectors are not a substitute for emergency medical treatment.

As with any medication, EpiPen Auto-Injector has an expiration date printed directly on the unit and shelf carton and should therefore be replaced when the unit expires. The product should be stored at room temperature and never refrigerated or kept where it might be exposed to extreme temperatures, such as in the glove compartment of a car.

Dey Pharma, L.P., the distributor of EpiPen Auto-Injector, offers patient support through free membership in the EpiPen Center for Anaphylactic Support (CAS) Program(TM). This program provides helpful tips, resources and an expiration reminder program.

Important Safety Information

Each EpiPen Auto-Injector contains a single dose of a medicine called epinephrine, which you inject into your outer thigh. DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT INTO YOUR BUTTOCK, as this may not be effective for a severe allergic reaction. 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.

Side effects may include an increase in heart rate, a 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. If you have high blood pressure or an overactive thyroid, these side effects may be more severe or longer lasting. If you have heart disease, you could experience chest pain (angina). If you have diabetes, your blood sugar levels may increase after use. If you have Parkinson's disease, your symptoms may temporarily get worse.

Talk to your doctor to find out if you should be prescribed an EpiPen or EpiPen Jr. Auto-Injector.

About Dey

Dey Pharma, L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL - News), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, severe allergic reactions and psychiatric disorders. The company puts patients first and facilitates efficient, cost-effective partnerships with customers.

About Mylan

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies.

EpiPen® is a registered trademark of Dey Pharma, L.P.

Source: Mylan