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Momenta Pharmaceuticals Announces Positive Outcome for Contracted Glatopa® (glatiramer acetate injection) Fill/Finish Manufacturer

MOMENTA PHARMACEUTICALS (MNTA)  More Company Research Source: GlobeNewswire
Last momenta pharmaceuticals earnings: 2/21 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: ir.momentapharma.com/investor-relations
PDF -- McPherson, Kansas facility compliance status amended to Voluntary Action Indicated (VAI)-- -- VAI status provides the potential for the near-term FDA approval of Sandoz’s Glatopa 40 mg ANDA-- CAMBRIDGE, Mass., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the FDA has classified the outcome of its fourth quarter 2017 reinspection of Pfizer’s McPherson facility as Voluntary Action Indicated (VAI). The Glatopa 40 mg ANDA remains under regulatory review, however, the Company believes the application review could be completed at any time in connection with the change to VAI status. “We are extremely pleased with this outcome. This past year of uncertainty regarding the resolution of the McPherson facility warning letter has been difficult for Momenta and its shareholders, but with this announced change in status we believe we are well-p [Read more]

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