TheraRadar

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Data updated: Mar 10, 2026

SANDOSTATIN LAR

OCTREOTIDE ACETATE
Oncology Approved 1998-11-25
3
Indications
--
Phase 3 Trials
2
Priority Reviews
27
Years on Market

Details

Status
Prescription
First Approved
1998-11-25
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: OCTREOTIDE ACETATE

SANDOSTATIN LAR Approval History

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What SANDOSTATIN LAR Treats

5 indications

SANDOSTATIN LAR is approved for 5 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acromegaly
  • Carcinoid Tumor
  • Diarrhea
  • Flushing
  • Vasoactive Intestinal Peptide Tumor
Source: FDA Label

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SANDOSTATIN LAR FDA Label Details

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Indications & Usage

FDA Label (PDF)

Octreotide Acetate Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumors (VIP...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.