Somatuline Depot Approval History

  • FDA approved: Yes (First approved August 30th, 2007)
  • Brand name: Somatuline Depot
  • Generic name: lanreotide acetate
  • Previous name: Somatuline Autogel
  • Company: Tercica, Inc.
  • Treatment for: Acromegaly

Somatuline Depot is a sustained-release injection formulation of lanreotide, a somatostatin analogue indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

FDA Approval History for Somatuline Depot

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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