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Somatuline Depot FDA Approval History

FDA Approved: Yes (First approved August 30, 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 timeline for Somatuline Depot

Jun 24, 2019Approval Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline Depot (lanreotide)
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

Further information

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