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FDA approves Ipsen's Somatuline Depot for GEP-NETs

December 17, 2014 2:16 AM UTC

FDA approved an sNDA under Priority Review for Somatuline Depot lanreotide acetate ( ITM-014) from Ipsen Group (Euronext:IPN; Pink:IPSEY) to treat rare gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Ipsen already markets the extended-release formulation of lanreotide, a somatostatin analog, as Somatuline Depot in the U.S. to treat acromegaly and in the EU as Somatuline Autogel to treat acromegaly and neuroendocrine tumors. ...