GEMCITABINE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2010-11-15
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
GEMCITABINE HYDROCHLORIDE Approval History
What GEMCITABINE HYDROCHLORIDE Treats
21 FDA approvalsOriginally approved for its first indication in 2010 . Covers 21 distinct patient populations.
- Other (21)
Other
(21 approvals)- • Approved indication (Nov 2010)Letter
- • Approved indication (Jan 2011)Letter
- • Approved indication (May 2011)
- • Approved indication (May 2011)
- • Approved indication (Jul 2011)
- • Approved indication (Aug 2011)Label Letter
- • Approved indication (Sep 2012)
- • Approved indication (Sep 2012)
- • Approved indication (May 2013)
- • Approved indication (Jan 2016)
- • Approved indication (Apr 2016)
- • Approved indication (May 2017)
- • Approved indication (Aug 2017)Label Letter
- • Approved indication (Dec 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Dec 2020)
- • Approved indication (Jun 2021)
- • Approved indication (Mar 2023)
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.
GEMCITABINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. • in combination with cisplatin, for the treatment of non-small cell lung cancer. • as a single agent for the treatment of pancreatic cancer. 1.1 Ovarian ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.