Teva: The FDA's Bombshell

10/6/17

FDA Approves Mylan's Generic Version Of Copaxone

Investors woke up to the news today that the U.S. Food and Drug Administration (FDA) has approved Mylan N.V.'s (NASDAQ:MYL) generic version of Teva Pharmaceutical Industries' (NYSE:TEVA) blockbuster branded drug, Copaxone (glatiramer acetate injection), for both the 40 mg/mL and 20 mg/mL versions used for the treatment of patients with relapsing forms of multiple sclerosis (MS). The company expects shipments to begin "imminently." The icing on the cake is the fact that Mylan and other first filers may be eligible for 180 days of generic drug exclusivity.

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