Press Releases

 
Press Releases
  Date Title and Summary View
Feb 16, 2017
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Feb. 16, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta®  (pegfi...
Feb 14, 2017
HERTFORDSHIRE, England and PITTSBURGH, Feb. 14, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today applauds the rebranding of the Generic Pharmaceutical Association (GPhA) to the Association for Accessible Medicines (AAM). Mylan CEO Heather Bresch commented, "The launch of GPhA's new brand - the Association for Accessible Medicin...
Feb 3, 2017
HERTFORDSHIRE, England and PITTSBURGH, Feb. 3, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that it will host an Investor Day on March 1, 2017 in New York City. Mylan CEO Heather Bresch and the company's senior leadership team will present the company's financial guidance for 2017 and an overview of the company's strategic vi...
Jan 30, 2017
HERTFORDSHIRE, England and PITTSBURGH, Jan. 30, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to Copaxone® 40 mg/mL invalid based on obviousness.  The invalid...
Jan 11, 2017
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Jan. 11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing t...
Jan 9, 2017
HERTFORDSHIRE, England and PITTSBURGH, Jan. 9, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that CEO Heather Bresch will present at the 35th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 11, 2017, in San Francisco. The presentation is scheduled to begin at 9:00 a.m. PST (12:00 p.m. EST). Interested p...
Jan 9, 2017
HERTFORDSHIRE, England and PITTSBURGH, Jan. 9, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that it has agreed to acquire global rights to Cold-EEZE® brand cold remedy line from ProPhase Labs, Inc. The 20-year old Cold-EEZE® brand includes a family of leading over-the-counter (OTC) cold remedies currentl...
Dec 29, 2016
HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a generic version of Janssen's Concerta® Tablets.  Mylan received final approval from the U.S. Food and Drug Administr...
Dec 29, 2016
HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Fosphenytoin Sodium Injection USP, 75 mg/mL, (50 mg PE*/mL), packaged in 100 mg PE*/2 mL, and 500 mg PE*/10 mL single-use vials, a generic version of Pfizer's Cerebyx® Injection. Mylan received final approval ...
Dec 28, 2016
HERTFORDSHIRE, England and PITTSBURGH, Dec. 28, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg / 0.05 mg. Mylan's product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Zovia® 1/50E-...
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