Dey Pharma, the Specialty Division of Mylan

Dey, 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, severe allergic reactions, and psychiatric disorders. The company puts patients first and facilitates efficient cost-effective partnerships with customers.

EpiPen 2-Pak® (epinephrine) and EpiPen Jr 2-Pak® (epinephrine)

EpiPen® (epinephrine) and EpiPen Jr (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.

Please see full Prescribing Information.
Please see the full Patient Insert.


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

Indication
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.

DEY12-9000

Perforomist® Inhalation Solution

PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation Solution. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS).

Important Safety Information
PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

PERFOROMIST Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

 
Please see full Prescribing Information, including Boxed Warning.

EMSAM® (selegiline transdermal system)

EMSAM® (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, EMSAM is designed to continuously deliver selegiline over a 24-hour period.

Antidepressants increase the risk compared to placebo of suicidality in children, adolescents and young adults. EMSAM is not approved for pediatric patients.


Please see full Prescribing Information, including Boxed Warning.