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Sold as Somatuline Depot, Lanreotide Acetate. Every FDA application for this active ingredient: 2 branded and 2 generic.
As of Nov 15, 2026, FDA lists 4 applications for Lanreotide Acetate (sold as Somatuline Depot, Lanreotide Acetate), first approved Aug 30, 2007, with 4 new uses approved and 0 published complete response letters.
First approved: Aug 30, 2007
Applications: 4
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $430M
First approved in Japan: Jun 29, 2012
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 58 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
SomatulineDrugs with a new indication for the treatment of thyroid- stimulating hormone secreting pituitary tumour. · Teijin Pharma Limited · Dec 25, 2020
SomatulineA drug with a new additional indication and a new dosage indicated for the treatment of neuroendocrine tumors of the pancreas and gastrointestinal tract. · Teijin Pharma Limited · Jul 3, 2017
Somatuline, new ingredientDrugs with a new active ingredient for the improvement of hypersecretion of growth hormone and IGF-I (somatomedin-C) and related symptoms in acromegaly and… · Teijin Pharma Limited · Jun 29, 2012
Clinical Trials
12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
