Press Releases

Date Title and Summary Additional Formats
Toggle Summary Mylan Announces the U.S. Patent and Trademark Appeal Board Institutes Inter Partes Review Proceedings on All Claims Against Sanofi's Lantus® Patents
HERTFORDSHIRE, England and PITTSBURGH , Dec. 14, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Patent and Trademark Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against two Orange Book-listed patents, U.S. Patent Nos.
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Toggle Summary Teva Dismisses Litigation After Mylan Wins U.S. Court Ruling Related to Teva's Cold Filtration Patents for Copaxone® 40 mg/mL
Teva also agrees to withdraw Irish equivalent to U.S. patents from litigation in Ireland
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Toggle Summary Mylan and Aspen Announce Launch of Generic Busulfex® Injection
HERTFORDSHIRE, England , PITTSBURGH and DURBAN, South Africa , Dec. 4, 2017 /PRNewswire/ --  Mylan N.V. (NASDAQ, TASE: MYL) and its partner, Aspen (JSE: APN), today announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka
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Toggle Summary U.S. FDA Approves Mylan and Biocon's Ogivri™, the First Biosimilar for Trastuzumab, for the Treatment of HER2-Positive Breast and Gastric Cancers
Mylan anticipates potentially being the first company to provide patient access to a biosimilar to Herceptin®, representing a significant milestone for Mylan, Biocon and the overall healthcare systemThe FDA approval of Ogivri further demonstrates Mylan and Biocon's robust scientific capabilities in developing complex productsOgivri is part of Mylan's robust portfolio of 16 biosimilar and insulin analog products, one of the largest and most diverse
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Toggle Summary FDA Approval of Heparin Sodium Injection Continues to Demonstrate Mylan's Deep Expertise in Developing Complex Products
HERTFORDSHIRE, England and PITTSBURGH , Dec. 1, 2017 /PRNewswire/ --  Mylan N.V. (NASDAQ, TASE: MYL), a global pharmaceutical company, today announced it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Heparin Sodium
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Toggle Summary European Medicines Agency Accepts Marketing Authorization Applications for Mylan and Biocon's Proposed Biosimilars Trastuzumab and Pegfilgrastim
HERTFORDSHIRE, England , PITTSBURGH and BENGALURU, India , Nov. 30, 2017 /PRNewswire/ --  Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON ) today announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applications
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Toggle Summary Mylan to Present at Evercore ISI Inaugural Biopharma Catalyst/Deep Dive Conference
HERTFORDSHIRE, England and PITTSBURGH , Nov. 20, 2017 /PRNewswire/ --  Mylan N.V. (NASDAQ, TASE: MYL) today announced that its president, Rajiv Malik , will present at the Evercore ISI Inaugural Biopharma Catalyst/Deep Dive Conference in Boston, Mass. , on Thursday, Nov. 30, 2017 , at 3:50 p.m.
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Toggle Summary Theravance Biopharma and Mylan Submit New Drug Application to FDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
Filing Supported by Positive Results from Two Pivotal Phase 3 Efficacy Studies and One 12-Month Phase 3 Safety Study
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Toggle Summary Mylan Announces Voluntary Delisting from the Tel Aviv Stock Exchange (TASE)
HERTFORDSHIRE, England and PITTSBURGH , Nov. 10, 2017 /PRNewswire/ --  Mylan N.V. (NASDAQ, TASE: MYL) today announced that it is voluntarily delisting the company's ordinary shares from trading on the Tel Aviv Stock Exchange (TASE). Under Israeli law, the delisting of Mylan's ordinary shares from
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Toggle Summary Mylan Launches Generic Clolar® for Injection
HERTFORDSHIRE, England and PITTSBURGH , Nov. 9, 2017 /PRNewswire/ --  Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials, a generic version of Genzyme's Clolar®. Mylan received final approval from the U.S.
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