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Ipsen (IPN.PA) Announces Acceptance Of Filings For Somatuline® In The Treatment Of GEP-NET1s In The U.S. With Priority Review And In Europe


9/2/2014 12:03:26 PM

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PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of its supplemental New Drug Application (sNDA) for Somatuline® Depot® 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. Decision is expected in early Q1, 2015.

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