throbber

`
`Mylan Launches Generic Version of Lidoderm® Patch - Aug 10, 2015
`
`News
`
`Mylan Launches Generic Version of Lidoderm®
`Patch
`
`Print
`
`HERTFORDSHIRE, England and PITTSBURGH, Aug. 10, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq:
`
`MYL) today announced the U.S. launch of its Lidocaine Patch 5%, which is the generic version of Endo
`
`Pharmaceutical's Lidoderm®. 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 relief of
`
`pain associated with post-herpetic neuralgia.
`
`Mylan CEO Heather Bresch said: "We are very pleased to launch our Lidocaine Patch 5%. Mylan's
`
`presentation of this product comes in the form of a thin, lightweight patch, and offers patients a high
`
`quality, affordable treatment option within the pain management space. We look forward to continue
`
`innovating to meet unmet needs as we deliver on our promise to bring complex, difficult-to-manufacture
`
`products to market to benefit patients, providers and payors in the U.S. and around the world."
`
`Lidocaine Patch 5% had U.S. sales of approximately $1.1 billion for the 12 months ending June 30,
`
`2015, according to IMS Health.
`
`Currently, Mylan has 266 ANDAs pending FDA approval representing $100 billion in annual brand sales,
`
`according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities,
`
`representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 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 nearly 50% 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 my|an.com.
`
`This press release includes statements that constitute "forward-looking statements," including with
`
`regard to sales of products and the company's strategy, future growth and performance. 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: the impacts of competition;
`
`http://newsroom .my|an.com/2015-08-10-My|an-Launches-Generic-Version-of-Lidoderm-Patch
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`NCI Exhibit 2051
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`1/2
`
`NCI Exhibit 2051
`
`

`
`Mylan Launches Generic Version of Lidoderm® Patch - Aug 10, 2015
`
`changes in economic and financial conditions of the company's business; strategies by competitors or
`
`other third parties to delay or prevent product introductions; risks inherent in legal and regulatory
`
`processes; uncertainties and matters beyond the control of management; and the other risks detailed in
`
`the company's filings with the Securities and Exchange Commission. The company undertakes no
`
`obligation to update these statements for revisions or changes after the date of this release.
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968; Kris King (Investors), 724.514.1813
`
`http://newsroom .my|an.com/201 5-08- 10-My|an-Launches- Generic-Version-of- Li doderm-Patch
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`Mylan Launches Generic Nexium® Delayed-Release Capsules - Aug 5, 2015
`
`News
`Select (cid:9)
`
`•
`
`Mylan Launches Generic Nexium® Delayed-
`Release Capsules
`
`HERTFORDSHIRE, England and PITTSBURGH, Aug. 5, 2015 /PRNewswire/ Mylan N.V. (Nasdaq:
`MYL) today announced the U.S. launch of Esomeprazole Magnesium Delayed-release Capsules USP,
`20 mg and 40 mg, which is the generic version of AstraZeneca's Nexium®. 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 gastroesophageal reflux disease (GERD) in adults
`and children ages 1 and older.
`
`Mylan CEO Heather Bresch commented: "Mylan's launch of Esomeprazole Magnesium Delayed-release
`Capsules USP represents our continued commitment to expand access to high quality medicine, and
`we're pleased to provide patients with another affordable treatment option. We look forward to continue
`delivering on our mission to set new standards in healthcare by expanding our broad portfolio of
`products in the U.S. and around the world."
`
`Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, had U.S. sales of
`approximately $5.2 billion for the 12 months ending June 30, 2015, according to IMS Health.
`
`Currently, Mylan has 268 ANDAs pending FDA approval representing $101.3 billion in annual brand
`sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities,
`representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 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 nearly 50% 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.
`
`This press release includes statements that constitute "forward-looking statements," including with
`regard to sales of products and the company's strategy, future growth and performance. 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
`
`http://newsroom .mylan.com/2015-08-05-Mylan-Launches-Generic-Nexi um-Delayed-Release-Capsules (cid:9)
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`
`

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`Mylan Launches Generic Nexi um® Delayed-Release Capsules - Aug 5, 2015
`
`could cause or contribute to such differences include, but are not limited to: the impacts of competition;
`changes in economic and financial conditions of the company's business; strategies by competitors or
`other third parties to delay or prevent product introductions; risks inherent in legal and regulatory
`processes; uncertainties and matters beyond the control of management; and the other risks detailed in
`the company's filings with the Securities and Exchange Commission. The company undertakes no
`obligation to update these statements for revisions or changes after the date of this release.
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968; Kris King (Investors), 724.514.1813
`
`http://newsroom .mylan.com/2015-08-05-Mylan-Launches-Generic-Nexi um-Delayed-Release-Capsules (cid:9)
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`
`Mylan One of First to Launch Generic Version of Namenda® Tablets - Jul 14, 2015
`
`News
`Select (cid:9)
`
`•
`
`Mylan One of First to Launch Generic Version of
`Namenda® Tablets
`
`- Company awarded 180 days shared marketing exclusivity -
`
`HERTFORDSHIRE, England and PITTSBURGH, July 14, 2015 /PRNewswire/ Mylan N.V. (Nasdaq:
`MYL) today announced the U.S. launch of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg,
`which is the generic version of Forest's Namenda® 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 moderate to severe dementia of the Alzheimer's type.
`
`Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, had U.S. sales of approximately $1.4 billion for
`the 12 months ending March 31, 2015, according to IMS Health. Mylan was one of the first ANDA
`applicants to submit a substantially complete ANDA with a paragraph IV certification and has therefore
`been granted 180 days of shared generic drug marketing exclusivity.
`
`Currently, Mylan has 270 ANDAs pending FDA approval representing $107.2 billion in annual brand
`sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file
`opportunities, representing $33.3 billion in annual brand sales, for the 12 months ending December 31,
`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 nearly 50% 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.
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968
`
`http://newsroom.mylan.com/2015-07-14-Mylan-One-of-First-to-Launch-Generic-Version-of-Namenda-Tablets (cid:9)
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`Mylan Launches First Generic Targretin® Capsules - Jul 9, 2015
`
`News
`Select (cid:9)
`
`•
`
`Mylan Launches First Generic Targretin®
`Capsules
`
`- 180 days of marketing exclusivity awarded-
`
`HERTFORDSHIRE, England and PITTSBURGH, July 9, 2015 /PRNewswire/ Mylan N.V. (Nasdaq:
`MYL) today announced the U.S. launch of Bexarotene 75mg Capsules, which is the generic version of
`Valeant's Targretin® Capsules. This product is indicated for the treatment of cutaneous manifestations
`of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy.(1)
`
`Mylan CEO Heather Bresch commented: "Mylan's launch of the first and only generic Targretin is
`another example of our commitment to expand access to high quality, more affordable medicines. The
`launch also strengthens Mylan's growing oncology franchise of more than 30 approved oncology
`treatments, and associated supportive care and diagnostic products in the U.S. We look forward to
`continue meeting patient, payor and provider needs in this space."
`
`Bexarotene 75mg Capsules had U.S. sales of approximately $155.5 million for the 12 months ending
`March 31, 2015, according to IMS Health.
`
`Currently, Mylan has 270 ANDAs pending FDA approval representing $107.2 billion in annual brand
`sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file
`opportunities, representing $33.3 billion in annual brand sales, for the 12 months ending December 31,
`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 nearly 50% 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.
`
`This press release includes statements that constitute "forward-looking statements," including with
`regard to sales of products and the company's strategy, future growth and performance. 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: the impacts of competition;
`http://newsroommylan.com/2015-07-09-Mylan-Launches-First-Generic-Targretin-Capsules (cid:9)
`
`1/2
`
`(cid:9)
`

`
`Mylan Launches First Generic Targretin® Capsules - Jul 9, 2015
`
`changes in economic and financial conditions of the company's business; strategies by competitors or
`other third parties to delay or prevent product introductions; risks inherent in legal and regulatory
`processes; changes in third party relationships; uncertainties and matters beyond the control of
`management; and the other risks detailed in the company's filings with the Securities and Exchange
`Commission. The company undertakes no obligation to update these statements for revisions or
`changes after the date of this release.
`
`(1) Targretin Capsules are a member of the retinoid class of drugs that is associated with birth defects
`in humans. Targretin Capsules must not be administered to a pregnant woman.
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968, Kris King (Investors), 724.514.1813
`
`http://newsroom.mylan.com/2015-07-09-Mylan-Launches-First-Generic-Targretin-Capsules (cid:9)
`
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`
`(cid:9)
`

`
` Mylan Launches First Bioequivalent Alternative to Combination Asthma Therapy Seretide® Evohaler® (Salmeterol Xi nafoate/Fluticasone Propionate) Und...
`
`News
`Select (cid:9)
`
`•
`
`Mylan Launches First Bioequivalent Alternative
`to Combination Asthma Therapy Seretide®
`Evohale o (Salmeterol Xinafoate/Fluticasone
`Propionate) Under the Brand Name Sirdupla TM
`in the UK
`
`Mylan becomes the first company to market a generic version of the UK's number one
`prescribed long-acting beta2-agonist + inhaled corticosteroid pressurized metered-dose inhaler
`asthma therapy[1],[2]
`
`HERTFORDSHIRE, England, and PITTSBURGH, June 8, 2015 /PRNewswire/ Mylan N.V. (Nasdaq:
`MYL) today announced that it has launched the first bioequivalent alternative to GlaxoSmithKline's
`Seretide® Evohaler® (salmeterol xinafoate/fluticasone propionate) under the brand name Sirdupla TM in
`the UK.[1] Sirdupla is a pressurized metered-dose inhaler (pMDI) and is indicated to help treat or prevent
`symptoms of asthma in adults 18 years of age and older.P114] The product is being manufactured by 3M
`Drug Delivery Systems.
`
`The UK has one of the highest rates of asthma in Europe, affecting one in five households, and, on
`average, three asthma patients in the UK die every day from the condition.[5] With 5.4 million people
`suffering from asthma in the UK, the condition costs the National Health Service (NHS) £1 billion (1.53
`billion USD) annually.[5]
`
`Mylan President Rajiv Malik said, "Mylan is excited to be the first company to offer adult asthma patients
`in the UK the generic version of Seretide Evohaler, delivering on our mission to increase access to high
`quality medicine. Sirdupla represents a significant advancement for the company that both strengthens
`our respiratory portfolio and pipeline and further demonstrates our ability to successfully execute on one
`of our key strategic growth drivers."
`
`Mylan Europe President Jacek Glinka added, "The launch of Mylan's Sirdupla broadens patient access
`to an important treatment option and offers a familiar pMDI device experience to UK asthma sufferers.
`Asthma is a widespread illness in the UK and we are committed to contributing to ease this burden to
`both patients and the NHS."
`
`"3M will fill, assemble and package Sirdupla at 3M's manufacturing facility in Loughborough, UK. By
`partnering with Mylan, 3M has taken an important step forward in the generics space. This partnership
`combines 3M's expertise in inhalation drug development and manufacturing with Mylan's leadership
`
`http://newsroom.mylan.com/2015-06-08-Mylan-Launches-First-Bioequivalent-Alternative-to-Combination-Asthma-Therapy-Seretide-Evohaler-Salmeterol-Xin... 1/3
`
`

`
`Mylan Launches First Bioequivalent Alternative to Combination Asthma Therapy Seretide® Evohaler® (Sal meterol Xi nafoate/Fluticasone Propionate) Und...
`position in the global generics market, including expertise in commercializing complex respiratory
`products," said Cindy Kent, President and General Manager — 3M Drug Delivery Systems.
`
`Sirdupla is a daily maintenance pressurized metered-dose inhaler that offers the same ease of use that
`patients expect from their asthma therapy. It is available in 125/25 mcg and 250/25 mcg with 120 doses.
`
`In line with the provisions of Article 106 of Directive 2010/84/EU, all of our Summary of Product
`Characteristics and Product Information Leaflets can be accessed on the website of the MHRA
`(http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/index.htm). For
`the identification of Mylan documents please use the Product Licence (PL) number.
`
`This press release includes statements that constitute "forward-looking statements," including with
`regard to sales of products, manufacturing and the Company's strategy, future growth and performance.
`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: the impacts of
`competition; changes in economic and financial conditions of the company's business; strategies by
`competitors or other third parties to delay or prevent product introductions; risks inherent in legal and
`regulatory processes; risks associated with international operations; uncertainties and matters beyond
`the control of management; and the other risks detailed in the company's filings with the Securities and
`Exchange Commission. The company undertakes no obligation to update these statements for revisions
`or changes after the date of this release.
`
`About Mylan
`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 or mylan.co.uk
`
`About 3M Drug Delivery Systems
`3M Drug Delivery Systems partners with pharmaceutical and biotech companies to develop and
`manufacture complex pharmaceutical products using 3M's inhalation, transdermal or microneedle drug
`delivery technology. 3M offers a full range of feasibility, development and manufacturing capabilities to
`help bring products to market. Regulatory expertise, quality assurance, operations, marketed product
`support and other in-house resources are available for each step of the development and
`commercialization process. For more information, please visit www.3M.com/dds or call 1-800-643-
`8086
`
`About 3M
`At 3M, we apply science in collaborative ways to improve lives daily. With $32 billion in sales, our 90,000
`employees connect with customers all around the world. Learn more about 3M's creative solutions to
`the world's problems at www.3M.com or on Twitter @3M or @3MNewsroom.
`
`[1] Data on file, Mylan.
`
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`

`
`Mylan Launches First Bioequivalent Alternative to Combination Asthma Therapy Seretide® Evohaler® (Sal meterol Xi nafoate/Fluticasone Propionate) Und...
`[2] IMS MAT. February 2015.
`
`[3] Sirdupla 125/25mcg Summary of Product Characteristics. May 2015.
`
`[4] Sirdupla 250/25mcg Summary of Product Characteristics. May 2015.
`
`[5] Asthma UK. Asthma facts and FAQs. http://www.asthma.org.uk/asthma-facts-and-statistics
`Accessed on April 30, 2015.
`
`Seretide® and Evohaler® are registered trademarks of Glaxo Group Limited.
`
`SOURCE Mylan N.V.
`
`For further information: 3M Contact: Michael Gugala, Karwoski & Courage, (612) 342-9604,
`m.gugala@creativepr.com; Mylan Contacts: Nina Devlin (Media), 724.514.1968, Kris King (Investors),
`724.514.1813
`
`http://newsroom.mylan.com/2015-06-08-Mylan-L_aunches-First-Bioequivalent-Alternative-to-Combination-Asthma-Therapy-Seretide-Evohaler-Salmeterol-Xin... 3/3
`
`

`
`Mylan Launches Generic Version of Seasonique® Tablets - Jun 2, 2015
`
`News
`Select (cid:9)
`
`•
`
`Mylan Launches Generic Version of
`Seasonique® Tablets
`
`HERTFORDSHIRE, England, and PITTSBURGH, June 2, 2015 /PRNewswire/ Mylan N.V. (Nasdaq:
`MYL) today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15
`mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg, which is the generic version of Teva's
`Seasonique® Tablets. Mylan's partner Famy Care Ltd. 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 prevention of pregnancy in women who elect to use oral contraceptives as a method of
`contraception.(1)
`
`Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP,
`0.01 mg, had U.S. sales of approximately $160.7 million for the 12 months ending March 31, 2015,
`according to IMS Health.
`
`Currently, Mylan has 271 ANDAs pending FDA approval representing $106 billion in annual brand sales,
`according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities,
`representing $32 billion in annual brand sales, for the 12 months ending December 31, 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) Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive
`use and this risk increases with age. Women who use oral contraceptives should be advised to not
`smoke. Consult your physician prior to beginning oral contraceptive use.
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968; Kris King (Investors), 724.514.1813
`
`http://newsroommylan.com/2015-06-02-Mylan-Launches-Generic-Version-of-Seasonique-Tablets
`
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`

`
`Mylan Launches Generic Version of Seasonique® Tablets - Jun 2, 2015
`
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`
`Mylan Launches Generic INTUNIV® Tablets - Jun 2, 2015
`
`News
`Select (cid:9)
`
`•
`
`Mylan Launches Generic INTUNIV® Tablets
`
`HERTFORDSHIRE, England, and PITTSBURGH, June 2, 2015 /PRNewswire/ Mylan N.V. (Nasdaq:
`MYL) today announced the U.S. launch of Guanfacine Extended-release Tablets, 1 mg, 2 mg, 3 mg,
`and 4 mg, which is the generic version of Shire's INTUNIV® 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 Attention Deficit Hyperactivity Disorder (ADHD) as
`monotherapy and as adjunctive therapy to stimulant medications.
`
`Guanfacine Extended-release Tablets, 1 mg, 2 mg, 3 mg, and 4 mg, had U.S. sales of approximately
`$804.9 million for the 12 months ending March 31, 2015, according to IMS Health.
`
`Currently, Mylan has 271 ANDAs pending FDA approval representing $106 billion in annual brand sales,
`according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities,
`representing $32 billion in annual brand sales, for the 12 months ending December 31, 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.
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968; Kris King (Investors), 724.514.1813
`
`http://newsroom .mylan.com/2015-06-02-Mylan-Launches-Generic-INTUN IV-Tablets (cid:9)
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`1/1
`
`(cid:9)

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