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Mylan files ANDA for generic Copaxone

Aug. 28, 2014 11:53 AM ETViatris Inc. (VTRS) StockBy: Douglas W. House, SA News Editor
  • The FDA accepts Mylan's (MYL -0.2%) ANDA for a 3x/week Glatiramer Acetate Injection 40 mg/mL which is a generic version of Teva's (TEVA -0.3%) Copaxone 40 mg/mL indicated for the treatment of patients with relapsing multiple sclerosis. Mylan believes it is one of the first companies to make the filing so it expects to be eligible for 180 days' market exclusivity (although this is based on the "first to file").
  • According to IMS Health, Copaxone generated ~$412M in U.S. sales over the 12-month period ending June 30, 2014.

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