Momenta Pharmaceuticals Announces FDA Warning Letter to Contracted Glatopa(R) (glatiramer acetate injection) Fill/Finish Manufacturer
Approval of the Glatopa 40 mg ANDA will be dependent on resolution of Pfizer facility compliance issues and Momenta expects that an approval in the first quarter of 2017 is unlikely
Warning letter does not restrict the production or shipment of Glatopa 20 mg
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