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Momenta Pharmaceuticals's Copaxone receives abbreviated new drug application for Copaxone from US Food and Drug Administration
1 September 2014 - United States-based Momenta Pharmaceuticals (MNTA:NASDAQ GS), has received the abbreviated new drug application for three-times-a-week generic, Copaxone (glatiramer acetate injection, 40mg/mL), submitted by Sandoz from the US Food and Drug Administration, it was reported on Friday.

The product is marketed for the treatment of Relapsing-Remitting Multiple Sclerosis. If the abbreviated new drug application is approved, the firm will be eligible for 180-day first-to-file exclusivity under Hatch-Waxman.

The product is to be launched in the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines.

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