Ipsen today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Somatuline Autogel (lanreotide acetate) 120 mg depot injection for the treatment of gastroenteropancreatic neuroendocrine tumors.
In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline Autogel 120mg injection to the drug regulatory authorities in 25 countries of the European Union.
Following EU and US submissions, Ipsen intends to implement worldwide submission roll-out.
For more details, go to: http://www.ipsen.com/wp-content/uploads/2014/07/PR-filing-Somatuline-GEP-NET-US-EU-FINAL.pdf