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`News
`Press Releases
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`Mar 11, 2015
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`Mylan Launches Generic Subutex® Sublingual
`Tablets
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`POTTERS BAR, England and PITTSBURGH, March 11, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL)
`and Mylan Inc. today announced the U.S. launch of Buprenorphine Hydrochloride Sublingual Tablets, 2 mg
`and 8 mg, which is the generic version of Reckitt Benckiser's Subutex® Sublingual Tablets. Mylan received
`final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application
`(ANDA) for this product, which is indicated for the treatment of opioid dependence and is preferred for
`induction.
`
`Buprenorphine Hydrochloride Sublingual Tablets, 2mg and 8mg had U.S. sales of approximately $107.8
`million for the 12 months ending December 31, 2014, according to IMS Health.
`
`Currently, Mylan has 281 ANDAs pending FDA approval representing $104.6billion in annual brand sales,
`according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities,
`representing $27.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS
`Health.
`
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working
`together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy
`unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact
`the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic
`pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral
`therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also
`operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in
`about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating
`better health for a better world, one person at a time. Learn more at mylan.com.
`
`To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mylan-
`launches-generic-subutex-sublingual-tablets-300048812.html
`
`SOURCE Mylan N.V.
`
`Company
`
`http://www.mylan.com/en/news/press-releases/item?id=123289
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`NCI Exhibit 2010
`Page 1 of 6
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`Mylan Launches Generic Subutex® Sublingual Tablets
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`http://www.mylan.com/en/news/press-releases/item?id=123289
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`NCI Exhibit 2010
`Page 2 of 6
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`Mylan Launches Generic Antabuse® Tablets - Mar 11,2015
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`Mylan Launches Generic Antabuse® Tablets
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`POTTERS BAR, England and PITTSBURGH, March 11, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ:
`MYL) and Mylan Inc. today announced the U.S. launch of Disulfiram Tablets USP, 250 mg and 500 mg,
`which is the generic version of Odyssey Pharmaceutical's Antabuse®. Mylan received final approval
`from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA)
`for this product, which is an aid in the management of selected chronic alcohol patients who want to
`remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be
`applied to the best advantage.(1)
`
`Disulfiram Tablets USP, 250 mg and 500 mg, had U.S. sales of approximately $16.4 million for the 12
`months ending December 31, 2014, according to IMS Health.
`
`Currently, Mylan has 282 ANDAs pending FDA approval representing $104.7 billion in annual brand
`sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file
`opportunities, representing $27.3 billion in annual brand sales, for the 12 months ending June 30,
`2014, according to IMS Health.
`
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working
`together around the world to provide 7 billion people access to high quality medicine, we innovate to
`satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy;
`and impact the future through passionate global leadership. We offer a growing portfolio of around
`1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of
`antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries
`depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and
`currently market products in about 145 countries and territories. Our workforce of approximately 30,000
`people is dedicated to creating better health for a better world, one person at a time. Learn more at
`mylan.com.
`
`(1) Disulfiram should never be administered to a patient when he is in a state of alcohol intoxication, or
`without his full knowledge. Disulfiram plus alcohol, even small amounts, produce flushing, throbbing in
`head and neck, throbbing headache, respiratory difficulty, nausea, copious vomiting, sweating, thirst,
`chest pain, palpitation, dyspnea, hyperventilation, tachycardia, hypotension, syncope, marked
`uneasiness, weakness, vertigo, blurred vision, and confusion.
`In severe reactions there may be
`respiratory depression, cardiovascular collapse, arrhythmias, myocardial infarction, acute congestive
`heart failure, unconsciousness, convulsions, and death.
`
`To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-
`releases/mylan-launches-generic-antabuse-tablets-300048810.html
`
`http://newsroom.mylan.com/index.php?s=2429&item=123288
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`NCI Exhibit 2010
`Page 3 of 6
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`Mylan Launches Generic Antabuse® Tablets - Mar 11,2015
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`Page 2 of 2
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`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968; Kris King (Investors), 724.514.1813
`
`http://newsroom.mylan.com/index.php?s=2429&item=123288
`
`NCI Exhibit 2010
`Page 4 of 6
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`Mylan Launches First and Only Available Intermediate Dosage Strengths of Fentanyl Transdermal System 37....
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`Mylan Launches First and Only Available
`Intermediate Dosage Strengths of Fentanyl
`Transdermal System 37.5,62.5and 87.5
`mcg/hr
`
`
`POTTERS BAR, England and PITTSBURGH, March 11, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq:
`MYL) and Mylan Inc. today announced the U.S. launch of its Fentanyl Transdermal System 37.5, 62.5
`and 87.5 mcg/hr, adding to its existing offering of Fentanyl Transdermal System 12, 25, 50, 75 and 100
`mcg/hr. Mylan currently is the only manufacturer that offers eight Fentanyl Transdermal System dosage
`strengths, including three new strengths –the first and only available "intermediate" dosages.
`
`Mylan CEO Heather Bresch commented: "Mylan's launch of Fentanyl Transdermal System 37.5, 62.5
`and 87.5 mcg/hr, is an example of our commitment to innovate to satisfy unmet needs. Mylan's
`Fentanyl Transdermal System is the number one dispensed fentanyl transdermal system in the U.S.i,
`and now, for the first time, patients have access to additional dosing options through Mylan's launch of
`three new strengths."
`
`Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Supplemental
`Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System 37.5, 62.5 and 87.5
`mcg/hr.
`
`Fentanyl Transdermal System's existing strengths, including the 12, 25, 50, 75 and 100 mcg/hr
`presentations, had U.S. sales of approximately $767 million for the 12 months ending September 30,
`2014, according to IMS Health.
`
`Currently, Mylan has 282 ANDAs pending FDA approval representing $104.6billion in annual brand
`sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file
`opportunities, representing $27.2 billion in annual brand sales, for the 12 months ending June 30,
`2014, according to IMS Health.
`
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working
`together around the world to provide 7 billion people access to high quality medicine, we innovate to
`satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy;
`and impact the future through passionate global leadership. We offer a growing portfolio of around
`1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of
`antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries
`
`http://newsroom.mylan.com/index.php?s=2429&item=123287
`
`NCI Exhibit 2010
`Page 5 of 6
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`Mylan Launches First and Only Available Intermediate Dosage Strengths of Fentanyl Transdermal System 37....
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`Page 2 of 2
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`depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and
`currently market products in about 145 countries and territories. Our workforce of approximately 30,000
`people is dedicated to creating better health for a better world, one person at a time. Learn more at
`mylan.com.
`
`i
`
`IMS Health, NPA™ , Dispensed Moving Annual Total (MAT) Prescriptions, December 2013
`through November 2014.
`
`To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-
`releases/mylan-launches-first-and-only-available-intermediate-dosage-strengths-of-fentanyl-
`transdermal-system-375-625-and-875-mcghr-300048809.html
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968 or Kris King (Investors), 724.514.1813
`
`http://newsroom.mylan.com/index.php?s=2429&item=123287
`
`NCI Exhibit 2010
`Page 6 of 6
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