Mylan's (MYL) Surprise Copaxone Generic Approval 'Quite Negative' for Teva Pharma (TEVA) - Mizuho
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Mylan Announces U.S. FDA Approval of First Generic for Copaxone® 40 mg/mL 3-Times-a-Week and May Be Eligible for 180-Day Exclusivity
October 3, 2017 9:58 PM EDTHERTFORDSHIRE, 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 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone® 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the... More
