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Somatuline Depot Approval History

  • FDA approved: Yes (First approved August 30th, 2007)
  • Brand name: Somatuline Depot
  • Generic name: lanreotide acetate
  • Dosage form: Injection
  • Company: Ipsen Biopharmaceuticals, Inc.
  • Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome

Somatuline Depot (lanreotide) is a long acting somatostatin analogue indicated for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.

Development History and FDA Approval Process for Somatuline Depot

Sep 18, 2017Approval FDA Approves New Indication for Ipsen’s Somatuline Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome
Dec 16, 2014Approval FDA Approves Somatuline Depot (lanreotide) for Gastroenteropancreatic Neuroendocrine Tumors
Aug 31, 2007Approval Ipsen: Somatuline Depot Receives Marketing Approval in the United States for the Treatment of Acromegaly
Jan 15, 2007FDA Accepts for Filing a New Drug Application (NDA) for Somatuline Autogel
Nov  2, 2006Tercica Reports Somatuline Autogel NDA for Acromegaly Submitted to FDA

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