Meridian manufactures EpiPen® Auto-Injector and Mylan Specialty markets and distributes the product in
Mylan Chief Executive Officer
Additional terms of the agreement are confidential, and the agreement itself is subject to review by the
About EpiPen Auto-Injector
EpiPen® (epinephrine) 0.3mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are for the emergency treatment of severe allergic reactions (anaphylaxis). As with any medication, EpiPen Auto-Injector has an expiration date printed directly on the side of the auto-injector and end side of the carton and should be replaced when the unit expires. The product should be stored at room temperature, protected from light and never refrigerated or kept where it might be exposed to extreme temperatures, such as in the glove compartment of a car.
EpiPen® and EpiPen Jr® (0.3 and 0.15 mg epinephrine) 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 INTRAVENOUSLY. DO NOT INJECT INTO YOUR BUTTOCK, as this may not be effective. 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.
If you take certain medicines, you may develop serious life-threatening side effects from the epinephrine in EpiPen Auto-Injectors. Be sure to tell your doctor all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure and heart disease. 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.
Please click here to view the EpiPen prescribing information.
Please click here for the EpiPen patient insert.
You are encouraged to report negative side effects of prescription drugs to the
Visit www.fda.gov/medwatch or call 1-800-
About Mylan Specialty
Mylan Specialty, a subsidiary of
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
Mylan Forward-Looking Statement: This press release includes statements that constitute "forward-looking statements," including with regard to the settlement and the marketing of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the
PFIZER DISCLOSURE NOTICE: The information contained in this release is of
This release contains forward-looking information that involves substantial risks and uncertainties regarding the settlement agreement and the marketing of the EpiPen Auto-Injector. Actual results may differ materially from those expressed in or implied by such forward-looking statements. Such risks and uncertainties include, among other things, the possibility of legal or regulatory challenges to the settlement agreement and the impact of competitive pressures on the marketing of the EpiPen Auto-Injector.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended
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