OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Post-LOEPeptide

octreotide acetate

Fresenius Kabi

ANDAINJECTIONINJECTABLE

Approved

Feb 2006

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

OCTREOTIDE ACETATE (PRESERVATIVE FREE) (octreotide acetate) by Fresenius Kabi is hormone, somatostatin. Approved for severe diarrhea, flushing episodes associated with metastatic carcinoid tumors, the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (vipomas)-secreting tumors and 2 more indications. First approved in 2006.

Drug data last refreshed 18h ago

Mechanism of Action

hormone, somatostatin. It is an even more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin,…

Indications (5)

severe diarrhea flushing episodes associated with metastatic carcinoid tumors

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (10)

NCT02195635Phase 1Completed

Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

Started Jul 2014

24 enrolled

Drug Interactions

NCT00376064Phase 4Completed

Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

Started Mar 2006

20 enrolled

Acromegaly

NCT00372697Phase 3Completed

Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

Started Dec 2005

28 enrolled

Acromegaly

NCT00248157Phase 3Terminated

Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

Started Nov 2005

105 enrolled

Diabetic Retinopathy

NCT00248131Phase 3Terminated

Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

Started Nov 2005

260 enrolled

Diabetic Retinopathy