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Data updated: Mar 10, 2026

OCTREOTIDE ACETATE (PRESERVATIVE FREE)

OCTREOTIDE ACETATE
Oncology Approved 2005-03-28
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2005-03-28
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

WEST-WARD PHARMS INT Viatris Fresenius Kabi SAGENT PHARMS INC WOCKHARDT USA
Active Ingredient: OCTREOTIDE ACETATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE) Approval History

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What OCTREOTIDE ACETATE (PRESERVATIVE FREE) Treats

5 indications

OCTREOTIDE ACETATE (PRESERVATIVE FREE) is approved for 5 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.

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

Drugs Similar to OCTREOTIDE ACETATE (PRESERVATIVE FREE)

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BYNFEZIA PEN
OCTREOTIDE ACETATE
5 shared
Sun Pharma
Shared indications:
AcromegalyCarcinoid TumorDiarrhea +2 more
SANDOSTATIN LAR
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Novartis
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AcromegalyCarcinoid TumorDiarrhea +2 more
ALOSETRON HYDROCHLORIDE
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AILEX PHARMS LLC
Shared indications:
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LANREOTIDE ACETATE
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INVAGEN PHARMS
Shared indications:
Acromegaly
LOMOTIL
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Pfizer
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LOTRONEX
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LEGACY PHARMA
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MOTOFEN
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LEGACY PHARMA
Shared indications:
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MYCAPSSA
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CHIESI
Shared indications:
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MYTESI
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NAPO PHARMS INC
Shared indications:
Diarrhea
NITAZOXANIDE
NITAZOXANIDE
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ANNORA PHARMA
Shared indications:
Diarrhea
PALSONIFY
PALTUSOTINE HYDROCHLORIDE
1 shared
CRINETICS
Shared indications:
Acromegaly
PARLODEL
BROMOCRIPTINE MESYLATE
1 shared
ESJAY PHARMA
Shared indications:
Acromegaly
R-GENE 10
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PHARMACIA AND UPJOHN
Shared indications:
Acromegaly
SODIUM BICARBONATE
SODIUM BICARBONATE
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Shared indications:
Diarrhea
SOMATULINE DEPOT
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IPSEN PHARMA
Shared indications:
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SOMAVERT
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1 shared
PHARMACIA
Shared indications:
Acromegaly
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Trial Timeline

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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.

OCTREOTIDE ACETATE (PRESERVATIVE FREE) FDA Label Details

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Indications & Usage

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

FDA Approval: ANDA076313 โ†’ Label: DailyMed โ†’ Trials: ClinicalTrials.gov โ†’

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