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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, Mylan innovates 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
Founders: Milan Puskar, and Don Panoz
CEO: Heather Bresch
CFO: Neil Dimick
824 articles with Mylan
2/23/2018Teva Pharmaceuticals will close its offices in Washington, D.C. and New York City as part of the cost-cutting measures.
Mylan Receives Tentative Approval for Combination HIV Treatment DTG/FTC/TAF Under FDA's PEPFAR Program
The antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.
The company will also host a webcast at 5:00 p.m. ET on Feb. 28, to discuss the results and 2018 guidance.
Mylan today announced the U.S. launch of Efavirenz Tablets USP, 600 mg, the first generic version of Bristol-Myers Squibb's Sustiva
Theravance Biopharma and Mylan Announce FDA Acceptance of NDA for Revefenacin (TD-4208) in Adults With COPD
The FDA has assigned a PDUFA target action date of November 13, 2018, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the NDA.
The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected in April.
Here’s a look at the top six generic drug companies to work for.
Mylan today announced that it is completing its previously-approved $1B share repurchase plan.
Momenta and Mylan Announce Development Strategy for M710, a Proposed Biosimilar to EYLEA (aflibercept)
The companies plan to initiate a pivotal clinical trial in patients in the first half of 2018.
Mylan Adds to U.S. Women's Healthcare Portfolio With FDA Approval of First Generic for Estrace Cream
Mylan N.V. today announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace Cream.
Biocon and Mylan's Biosimilar Trastuzumab Receives Approval From ANVISA, Brazil Through Their Partner Libbs
Libbs will commercialize the product in Brazil under the brand name Zedora, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil.
Mylan Announces the U.S. Patent and Trademark Appeal Board Institutes Inter Partes Review Proceedings on All Claims Against Sanofi's Lantus Patents
Mylan today announced that the U.S. PTAB has instituted IPR proceedings on all claims against two Orange Book-listed patents, U.S. Patent Nos. 7,476,652 and 7,713,930, owned by Sanofi for Lantus 100 Units/mL.
A look at the latest batch of FDA approvals this year.
Teva Dismisses Litigation After Mylan Wins U.S. Court Ruling Related to Teva's Cold Filtration Patents for Copaxone 40 mg/mL
Mylan today announced that Teva has dismissed its pending district court litigation against Mylan regarding Mylan's Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL.
As part of its partnership with Aspen, Mylan will commercialize Busulfan Injection, 60 mg/0 mg Single-dose Vial in the U.S.
FDA Approval of Mylan's Heparin Sodium Injection Continues to Demonstrate Mylan's Deep Expertise in Developing Complex Products
Mylan today announced it has received final approval from the FDA for its ANDAs for Heparin Sodium Injection USP, 1,000 USP/mL, 5,000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.
U.S. FDA Approves Mylan and Biocon's Ogivri, the First Biosimilar for Trastuzumab, for the Treatm...
12/1/2017Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the U.S.
Speculation has increased that Amazon might enter the pharmacy market after it conducted high-level talks with generic drug companies Mylan and Sandoz, a division of Novartis.
EMA acceptance of the submissions follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon's drug product facility.
11/30/2017As 2017 comes to a close, 40 drugs have been approved so far, with the record being in 2015, when 46 drugs were approved.