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Biotech / Medical : Momenta Pharmaceuticals Inc.

MNTA 52.48

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Oct 2 5:00 PM EST

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From: nigel bates	1/30/2018 10:30:18 AM
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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-positioned to gain marketing approval and launch our Glatopa 40 mg in the first half of 2018,” stated Craig Wheeler, Momenta CEO. “We remain committed to our goal of providing patients with relapsing forms of multiple sclerosis a more affordable, high-quality treatment option.”

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