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Omeros Corp Submits New Drug Application to U.S. FDA for OMS302


Thursday, 1 Aug 2013 07:00am EDT 

Omeros Corp announced that the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery. In addition, Omeros plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA) via the EMA's centralized procedure this quarter. The Company has recently been granted designation by the EMA as a Small or Medium-Sized Enterprise (SME). Through the SME program, Omeros can benefit from elimination or reduction of certain fees related to the clinical development and approval processes in Europe for OMS302 and other Omeros products. 

Company Quote

13.2
-0.4 -2.94%
19 Sep 2014