The Pfizer facility is a key part of the supply chain for the Company’s Glatopa products. Pfizer has indicated that the warning letter does not restrict the production or shipment of the Glatopa 20 mg (glatiramer acetate injection) product that is currently marketed by Sandoz in the United States.
The Glatopa 40 mg ANDA remains under regulatory review. The Company believes the application review could be completed at any time.
However, under FDA policy, an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product, and Momenta expects that an approval in the first quarter of 2017 is unlikely.
Momenta is working with its collaboration partner Sandoz to resolve this matter in order to allow for an ANDA approval as soon as possible.