JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced safety and tolerability results representing 25 years of data from the open-label extension study of the original U.S. pivotal trial of COPAXONE®(glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (RMS). The extension study initially examined …
Tag Archives: Copaxone
October, 2018
October, 2017
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4 October
FDA Approves Mylan’s Generic Version of Teva’s Multiple Sclerosis Drug Copaxone
HERTFORDSHIRE, England, and PITTSBURGH, Oct. 3, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone® 40 …
April, 2015
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21 April
Teva Confirms Speculations with Unsolicited Offer to Acquire Mylan for $40.1 Billion
Teva has confirmed speculations of a possible Mylan takeover bid, announcing a proposal to purchase all of the outstanding shares of Mylan for about $40.1 billion. Teva, the world’s largest generics drugmaker, made an unsolicited offer to acquire the company in a cash and stock transaction valued at $82 per …
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16 April
Sandoz Receives FDA Approval for the First Generic Version of Teva’s Multiple Sclerosis Drug Copaxone
Today, the US Food and Drug Administration (FDA) approved the first generic version of Teva Pharmaceuticals’ top-selling multiple sclerosis drug Copaxone (glatiramer acetate injection). The agency approved Sandoz’s Abbreviated New Drug Application (ANDA) for once daily Glatopa 20 mg/mL, a generic equivalent of daily Copaxone 20 mg. Glatopa is now …