OCTREOTIDE ACETATE
Details
- Status
- Prescription
- First Approved
- 2005-04-08
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
OCTREOTIDE ACETATE Approval History
What OCTREOTIDE ACETATE Treats
15 FDA approvalsOriginally approved for its first indication in 2005 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Apr 2005)
- • Approved indication (Oct 2005)
- • Approved indication (Nov 2005)
- • Approved indication (Feb 2006)
- • Approved indication (Aug 2007)
- • Approved indication (Mar 2008)
- • Approved indication (May 2011)
- • Approved indication (Nov 2013)
- • Approved indication (Sep 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Jun 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Dec 2023)
- • Approved indication (May 2024)
- • Approved indication (Dec 2025) New
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 FDA Label Details
ProIndications & 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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.