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Mylan's marketing application for long-acting insulin under review in Europe

Nov. 03, 2016 9:44 AM ETViatris Inc. (VTRS) StockBy: Douglas W. House, SA News Editor3 Comments
  • The European Medicines Agency (EMA) accepts for review Mylan N.V.'s (MYL +0.7%) Marketing Authorization Application (MAA) seeking approval of its insulin glargine, a long-acting insulin analog used to treat adult type 2 diabetics and adult and pediatric type 1 diabetics.
  • Mylan co-developed the product with Bengaluru, India-based Biocon Ltd. Clinical studies showed bioequivalence to Sanofi's (SNY +1%) Lantus (insulin glargine injection 100 Units/mL).

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