Transdermal Products
Proprietary Transdermal Technology
Mylan Technologies Inc. (MTI) is the market leader in generic transdermal drug delivery systems (TDDS) and related technologies. MTI has developed a variety of generic transdermal products available for the U.S. and International markets, and is one of the largest producers of transdermal products in North America. We have built a reputation for delivering exceptional quality through our vertically integrated manufacturing process and modern manufacturing facility.
Advanced TDDS Systems
Currently marketed products include Clonidine, Nitroglycerin, Estradiol, Fentanyl and EMSAM®1 transdermal systems. Our Fentanyl patch was the first generic class II narcotic TDDS ever approved. It is an AB-rated alternative to the equivalent branded drug, Duragesic®2.
Fentanyl 
Our Fentanyl transdermal patch, which received FDA approval on January 28, 2005, provides continuous delivery of fentanyl over 72 hours for the management of persistent, moderate to severe chronic pain in patients already receiving opioid treatment who require continuous and extended opioid administration and who cannot be managed by other means.
Fentanyl transdermal system is a potent Schedule II opioid; these drugs have the highest potential for abuse and associated risk of fatal overdoses due to respiratory depression. The high content of fentanyl in the patches may be a particular target for abuse and diversion.
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Nitroglycerin
Our first generic transdermal patch received approval from the FDA on August 30, 1996. This product is prescribed for the prevention of angina pectoris related to coronary artery disease.
The onset of action of transdermal nitroglycerin is not sufficiently rapid for the product to be useful in aborting an acute attack. It is contraindicated in patients using Viagra (sildenafil) because sildenafil may amplify the vasodilatory effects of Nitroglycerin Transdermal System resulting in severe hypotension.
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Estradiol
Our Estradiol transdermal patch received regulatory approval on February 24, 2000. This product is used to treat certain symptoms of menopause, hypoestrogenism, and for the prevention of post menopausal osteoporosis.
Estrogens increase the risk of endometrial cancer. They should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported that in post-menopausal women (50 to 79 years of age) estrogens were associated with increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, deep vein thrombosis, and increased risk of dementia (65 years and older).
Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
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Clonidine
On July 16, 2010, MTI received approval from the FDA for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day and is indicated for the treatment of hypertension. This product is a generic version of Boehringer Ingelheim's Catapres-TTS®3.
Clonidine Transdermal System should not be discontinued without first consulting a health care professional as the abrupt discontinuation of this medication may cause a sudden rise in blood pressure and in rare instances lead to hypertensive encephalopathy, cerebrovascular accidents or death. Use of clonidine has been associated with generalized skin rashes, urticaria and angioedema. Clonidine transdermal system should be used with caution in individuals with a history of severe coronary insufficiency, conduction disturbances, recent heart attack or chronic renal failure. Clonidine transdermal system may cause drowsiness, which can be potentiated by concomitant use of alcohol or other sedating drugs. Care should be employed when engaging in potentially hazardous activities.
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EMSAM®1
Somerset Pharmaceuticals, Inc., a wholly owned subsidiary of Mylan Inc., received approval from the FDA for EMSAM® transdermal Selegiline, on February 27 of 2006. EMSAM® is the first transdermal treatment for major depressive disorder. All aspects of the EMSAM® product related to its design, chemistry, manufacturing and controls were the result of the integration of the talents and expertise of MTI scientists. EMSAM® is manufactured by Mylan Technologies.
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psychotic disorders. Anyone considering the use of EMSAM® or other antidepressants in a child or adolescent must balance this risk with the clinical need.
EMSAM® is not indicated for use in pediatric patients.
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