Approval of the Glatopa 40 mg ANDA will be dependent on resolution of Pfizer facility compliance issues
Warning letter does not restrict the production or shipment of Glatopa 20 mg
The Glatopa 40 mg ANDA remains under regulatory review. The Company believes the application review could be completed at any time. However, under
Momenta plans to provide a further update on the status of the Glatopa 40 mg product candidate on its fourth quarter and year-end 2016 conference call and webcast. The call will be held on
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications.
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Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including without limitation the timing of the completion of review of the Glatopa 40 mg ANDA, the timing of Glatopa 40 mg approval, and the timing of further updates on the status of Glatopa 40 mg are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "believe," "expect," "plan," "unlikely," or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
MOMENTA INVESTOR CONTACT:
Sarah Carmody Momenta Pharmaceuticals1-617-395-5189 IR@momentapharma.com MOMENTA MEDIA CONTACT: Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com
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