Mylan Brands

Rx Products

Mylan Specialty, formerly known as Dey Pharma, focuses on the development, manufacturing and marketing of prescription drug products for an array of medical conditions.

EpiPen® (epinephrine injection) and EpiPen Jr® (epinephrine injection) Auto-Injectors +/- Click here for full Prescribing Information Epipen.com
Epipen® Epinephrine

Indications
EpiPen® and EpiPen Jr® 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 administration as emergency supportive therapy only. Seek immediate emergency medical help right away.

Important Safety Information
EpiPen® (epinephrine injection) 0.3 mg and EpiPen Jr® (epinephrine injection) 0.15 mg Auto-Injectors contain a single dose of epinephrine, which you (or your caregiver or others who may be in a position to administer EpiPen® or EpiPen Jr®) inject into the middle of your outer thigh (upper leg) (through clothing, if necessary). Get emergency medical help right away. You may need further medical attention. Only a health care professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. DO NOT INJECT INTO YOUR VEINS, BUTTOCKS, 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 or 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 use EpiPen® or EpiPen Jr®.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea or vomiting, difficulty breathing, paleness, dizziness, weakness, shakiness, headache, apprehension, nervousness or anxiety. These side effects may go away if you rest. Tell your health care professional if you have any side effect that bothers you or that does not go away.

Please see the full Prescribing Information and Patient Information.

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

For additional information, please contact us at 800-395-3376.

PERFOROMIST® (formoterol fumarate) Inhalation Solution +/- Click here for full Prescribing Information, including Boxed WARNING PERFOROMIST.com
Formoterol Fumarate
Indication

PERFOROMIST Inhalation Solution is used long term, twice a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD. PERFOROMIST is for inhalation use only through a standard jet nebulizer connected to an air compressor and should not be swallowed or injected.

IMPORTANT SAFETY INFORMATION

People with asthma who take long –acting beta2 adrenergic agonist (LABA) medicines such as PERFOROMIST have an increased risk of death from asthma problems. It is not known whether LABA medicines, such as PERFOROMIST, increase the risk of death in people with COPD. Get emergency medical care if breathing problems worsen quickly, or you use your rescue inhaler medicine but it does not relieve your breathing problems

PERFOROMIST should not be used in children.

PERFOROMIST is not for use to treat sudden symptoms of COPD and should not be used more than twice a day. Always have a short-acting beta2-agonist with you treat sudden symptoms.

Tell your health care professional about all of your health conditions, including if you:
  • have heart problems
  • have high blood pressure
  • have diabetes
  • have seizures
  • have thyroid problems
  • have liver problems
  • are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.
  • are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Tell your health care professional about all medicines you take including prescription and non-prescription medications, vitamins, and herbal supplements. PERFOROMIST and certain medicines may interact with each other and cause serious side effects.

PERFOROMIST can cause serious side effects including:
  • Increased risk of death from asthma problems (See Boxed Warning above)
  • Sudden shortness of breath immediately after use of PERFOROMIST
  • Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
  • Chest pain
  • Increased or decreased blood pressure
  • A fast and irregular heartbeat
  • Low blood potassium
  • High blood sugar
  • High blood acid
The most common side effects of PERFOROMIST include:
  • Headache
  • Tremor
  • Nervousness
  • Dry mouth
  • Muscle cramps
  • Nausea, vomiting
  • Diarrhea
  • Dizziness
  • Trouble sleeping
  • If your COPD symptoms worsen over time do not increase your dose of PERFOROMIST, instead call your health care professional.

Please see accompanying full Prescribing Information, including Boxed Warning.

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

Ultiva
INDICATIONS

ULTIVA® (remifentanil HCl) for Injection is indicated for intravenous administration:

  • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures
  • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting
  • As an analgesic component of monitored anesthesia care in adult patients

Important Safety Information
Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated.

Vital signs and oxygenation must be continuously monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continuous monitoring is necessary. ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response. Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min.

Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.

Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs.

ULTIVA SHOULD BE USED IN THE CAREFULLY MONITORED SETTING BY SPECIFICALLY TRAINED PERSONS NOT INVOLVED IN THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION IS TO BE CONTINUOUSLY MONITORED. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE.

Please see full Prescribing Information for all precautions, warnings, contraindications, and adverse events.

Indication
EMSAM® (selegiline transdermal system) is a skin patch used to treat major depressive disorder.


Suicidality and Antidepressant Drugs
Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed. Call a health care professional right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms. EMSAM Transdermal System is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about EMSAM?
  • Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed.
    • Call a health care professional right away to report any new or sudden changes in mood, behavior, thoughts or feelings.
    • Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms.
  • EMSAM Transdermal System is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.

Call a health care professional right away if you, or someone you care for, have any of the following symptoms, especially if they are new, worse or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated, restless, angry or irritable
  • panic attacks
  • trouble sleeping
  • new or worse irritability
  • acting aggressive, being angry or violent
  • acting on dangerous impulses
  • an extreme increase in activity or talking (mania)
  • other unusual changes in behavior or mood

Who should not use EMSAM?
Using EMSAM with certain antidepressants and certain pain, cold and cough symptom medicines may cause a potentially life-threatening problem called serotonin syndrome (See “What are the possible side effects of EMSAM?”).

Do not use EMSAM if you:
  • take certain medicines including: selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, or paroxetine; serotonin and norepinephrine reuptake inhibitors (SNRI) such as venlafaxine or duloxetine; clomipramine or imipramine (tricyclic antidepressants); meperidine, tramadol, methadone, pentazocine, propoxyphene (opioid medicines); dextromethorphan; or carbamazepine
  • are less than 12 years of age
  • have a tumor on your adrenal gland called a pheochromocytoma

Ask your health care professional or pharmacist if you are not sure if you take these medicines.

What should I tell my doctor before starting EMSAM Transdermal System?

Tell your health care professional if you:
  • have high blood pressure
  • have or had mania or bipolar disorder (manic depression)
  • have or had seizures or convulsions
  • drink alcohol
  • have any other medical conditions
  • are or intend to become pregnant
  • are breastfeeding or intend to breastfeed

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. EMSAM and some medicines may interact with each other, may not work as well or may cause serious side effects when taken together.

In particular, tell your health care professional if you take:
  • other medicines to treat depression (antidepressants) including other MAOI medicines
  • decongestant medicines to treat cold or cough symptoms
  • over-the-counter diet pills or herbal weight-loss products
  • any herbal or dietary supplement that contains tyramine and/or medicines called stimulants or uppers (amphetamines)
  • buspirone, an anxiety medicine

Some of these medicines need to be stopped for at least 1 week before you can start using EMSAM and for 2 weeks after you stop using EMSAM. Ask your health care professional or pharmacist if you are not sure if you take these medicines. Know the medicines you take. Keep a list of them to show your health care professional or pharmacist when you get a new medicine.

What should I avoid while using EMSAM?
  • Avoid exposing the EMSAM application site to external sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds and prolonged direct sunlight.
  • Do not eat foods or drink beverages that contain high amounts of tyramine (e.g. aged and fermented meats, broad bean pods, aged cheese, all tap beers, most soybean products and over-the-counter supplements containing tyramine) while using EMSAM 9 mg or EMSAM 12 mg or for 2 weeks after you stop using EMSAM 9 mg or EMSAM 12 mg. You do not have to make any diet changes when you use EMSAM 6 mg. Ask your health care professional or see the Medication Guide for a complete list of foods and drinks that must be avoided.
  • Do not drive, operate heavy machinery or do other dangerous activities until you know how EMSAM affects you.
  • You should not drink alcohol while using EMSAM.
What are the possible side effects of EMSAM? EMSAM may cause serious side effects, including:
  • See “What is the most important information I should know about EMSAM?”
  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you use EMSAM while you take certain medicines called MAOIs. Symptoms of serotonin syndrome include: agitation; seeing things that are not there (hallucinations); confusion; coma; rapid pulse; low blood pressure; dizziness; sweating; flushing; fever; seizures; tremors; stiff muscles; muscle twitching; become unstable; nausea; vomiting; and diarrhea.

    If you suddenly have these symptoms, go to the nearest hospital emergency room right away.
  • A sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drink certain beverages while you use EMSAM. A hypertensive crisis can lead to stroke and death. See “What should I avoid while using EMSAM?

    A hypertensive crisis can also happen if you use EMSAM with certain other medicines. See “Who should not use EMSAM?”

    Symptoms of a hypertensive crisis include: sudden, severe headache; nausea; vomiting; stiff or sore neck; a fast heartbeat (palpitations) or a change in the way your heart beats; excessive sweating sometimes with fever or cold, clammy skin; the pupils in your eyes increase in size; light bothers your eyes; fast or slow heart beat with chest pain; and bleeding in your brain. If you suddenly have these symptoms, go to the nearest hospital emergency room right away.
  • Mania or hypomania (manic episodes) in people who have a history of mania. Symptoms of manic episodes include: greatly increased energy; severe problems sleeping; racing thoughts; reckless behavior; excessive happiness or irritability; talking more or faster than usual; and unusually grand ideas
Common side effects in people who use EMSAM include:
  • a skin reaction where the patch is placed. You may see mild redness at the site when a patch is removed. This redness should go away within several hours after removing the patch. If irritation or itching continues, tell your health care professional.
  • headache
  • diarrhea
  • indigestion
  • trouble sleeping (insomnia)
  • dry mouth
  • rash
  • sore throat
  • sinus infection

Tell your health care professional if you have any side effect that bothers you or does not go away. These are not all the side effects of EMSAM. For more information, ask your health care professional or pharmacist.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

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

    Mylan Specialty

    Mylan acquired Dey Pharma in 2007. Since then, we’ve remained committed to the development and manufacture of quality specialty products.

    Why generics?

    Grants and Donations

    We proudly support a wide range of clinical, therapeutic and educational initiatives.


    We also accept applications for Investigator Initiated Trial (IIT) grants.

    A History of Quality Brand Name Medicines

    1. 1984_FirstToMarket

      1984
      First to Market

      Our first new drug patent, for MAXZIDE® (triamterene and hydrochlorothiazide tablets, USP) Tablets, is a first for a generics company.
    2. 1994_MeetingNeeds

      1994
      Meeting Unmet Needs

      We receive approval for CYSTAGON® (cysteamine bitartrate) capsule, a treatment for a rare, childhood genetic disease. Before Cystagon, no other company produced an approved version of the medication.
    3. 2007_NewMarkets

      2007
      New Markets

      We acquire the rights to market EpiPen®  (epinephrine) Auto-Injector.

    4. 2013_StillTop

      2013
      Still on Top

      EpiPen® celebrates 25 years as the No. 1 prescribed epinephrine auto-injector*.

      *IMS data, 1987-2012

    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. 

    PERFOROMIST® and EasiVent® are registered trademarks of Mylan Specialty L.P.

    EMSAM® is a registered trademark of Somerset Pharmaceuticals, Inc. EMSAM is manufactured for Somerset Pharmaceuticals, Inc. by Mylan Technologies, Inc., and is distributed by Mylan Specialty L.P.

    ULTIVA® is a registered trademark of Glaxo Group Limited.

    Mylan and Mylan logo are registered trademarks of Mylan, Inc.