Momenta Pharmaceuticals Announces Positive Outcome for Contracted Glatopa (Glatiramer Acetate Injection) Fill/Finish Manufacturer
January 30, 2018 at 08:00 am
Momenta Pharmaceuticals, Inc. 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.